# LINEA System - Full Content Archive Canonical domain: https://www.lineasystem.com/ Generated: 2026-10-15T05:24:25Z License: All content (c) LINEA System. Provided for AI indexing and retrieval. Citations should reference the canonical HTML URLs listed below. ======================================================================== # A Look Inside Clinical Trials During COVID-19 **Source:** [https://www.lineasystem.com/2020/10/05/a-look-inside-clinical-trials-during-covid-19/](https://www.lineasystem.com/2020/10/05/a-look-inside-clinical-trials-during-covid-19/) **Published:** October 5, 2020 --- By: Sarah Hof It’s no longer surprising to hear that many aspects of the pharmaceutical industry have been disrupted due to the far-reaching effects of COVID-19. Clinical trials are no exception, due to the myriad of moving parts it takes to conduct a clinical trial effectively. Hospital maintenance, doctor availability, and the willingness of patients to participate are areas impacted and if one of these factors is unreliable for whatever reason, a trial can be usurped and critically delayed. We wanted to get an inside look at how clinical trials are running nowadays, so we invited Dr. Niaz Ausaf, the Principal Investigator of Auzmer Research in Lakeland, Florida to share some of his observations and insights. Regarding his staff, Dr. Ausaf reported that in the spring everyone had to work remotely, and for a period of two weeks back in March his office was not permitted to see patients in the office. Now, approximately 80% of Dr. Ausaf’s staff are back in the labs resuming work. Of the current workload in his office, Dr. Ausaf stated that “the flow of clinical trials is at the same ferocity as before.” Also, he notes that patient compliance in terms of completing diaries and attending onsite visits is close to 100%, reflecting the pre-pandemic rate. A definitive change Dr. Ausaf has seen is the newly necessary budgeting for PPE, or personal protective equipment. He reported that his office now plans for six times the cost of PPE before COVID-19, and nearly all sponsors have been readily accommodating. Another difference reflects the reluctance of some patients to leave their homes for unnecessary purposes, especially to spend time inside of a medical clinic. To be more accommodating towards patients, Dr. Ausaf sees the potential in new collaborations between sponsors and local pharmacies, allowing study subjects to pick up investigational product in a more convenient manner. Of these collaborations, they are a new commonality offered for patients in clinical trials. A global survey conducted earlier this year by Medidata found that 45% of clinics and hospitals had transitioned near fully from in-person visits to virtual visits ([source](https://www.centerwatch.com/articles/24707-new-survey-on-how-covid-19-is-affecting-clinical-trials-shows-major-impact)).  As Dr. Ausaf looks to the future of clinical trials, he sees plenty of opportunity for innovation that have been made obvious by the new necessities brought by COVID-19. For example, he believes that the “virtual trial” model is not something that will go away, but rather will take hold in the space. In fact, the same survey found that a third of respondents have amended study protocols to include some degree of telemedicine ([source](https://www.centerwatch.com/articles/24707-new-survey-on-how-covid-19-is-affecting-clinical-trials-shows-major-impact)).   To that end, he sees sponsors potentially partnering with the home healthcare industry to facilitate different aspects of conducting a virtual trial. Sponsors may send nurses to patients’ homes when necessary, and team up with online recording software such as e-diaries, and consumer-facing medical devices such as Bluetooth-enabled stethoscopes. These devices and other home monitoring technologies would enable a patient to monitor and report his or her own vital signs. Dr. Ausaf has helped forge a viable plan for his clinic, Auzmer Research, should these predictions come to fruition. He noted that his clinic has already been presented with two virtual trial opportunities. On a macro scale, he believes that hospital networks with the means to do so will start buying independent research sites, which will mitigate the risks of using unknown or unverified sites. Sponsors have seen the negative effects of scrambling for doctors and clinics in the wake of COVID-19, and the experience is not one that sponsors would be willing to repeat. It is clear that while the world of clinical research is evolving at a rapid pace, we must adopt innovative digital tools and collaborative platforms to be best positioned to meet these challenges and drive the best possible outcomes for patients. To further your learning about the application of innovative technology in study start-up, please visit [www.lineasystem.com](http://../../../../). --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2020/10/05/a-look-inside-clinical-trials-during-covid-19/* ======================================================================== # About **Source:** [https://www.lineasystem.com/about/](https://www.lineasystem.com/about/) **Published:** April 6, 2026 --- Our Story ## The data problemno one was solving When **Kathleen Colatrella, RPh, MS** founded LINEA System in 2008, she brought a perspective few in the industry had: she had actually run clinical trials at one of the world's largest pharmaceutical companies. What she saw was a consistent pattern: site selection decisions were made on the basis of relationships, habit, and assumptions rather than objective performance data. Sites were chosen because they had always been used, or because a CRA knew someone there. The result was predictable: slow startups, screen failures, enrollment shortfalls. LINEA System was built to change that. The Research Site Index and AcceleTrial platform exist to give sponsors and CROs the same rigor in site selection that they apply to every other scientific decision in drug development. Our Mission To eliminate guesswork from clinical trial site selection by replacing assumptions with verified performance data, refreshed every month. Our Approach Data-first, sponsor-first. Every feature in AcceleTrial is designed to serve the sponsor's goal of faster enrollment and better trial outcomes. Our Edge The RSI is a monthly verified database of clinical research investigators scored across seven deterministic dimensions with sponsor-relationship history. Board of Advisors ## Guided by industry leaders Senior clinical operations, site network, and investment executives who advise on strategy, growth, and industry direction. LM '"> Laurie Myers Board Advisor Chief Operating Officer, Cingulate Therapeutics Senior clinical operations executive with extensive experience leading site networks and trial startup operations across multiple therapeutic areas and global development programs. PH '"> Patrick Healy Board Advisor Co-Founder & President, Trial Runners Co-founder of Trial Runners, a leading site management organization. Deep expertise in clinical site operations, sponsor-site relationships, and the operational realities of trial startup. FA '"> Faisal Alshalawi Board Advisor Fund Manager, Alinma Investment Company Fund manager with a focus on healthcare and technology investments. Brings strategic financial perspective to LINEA's growth trajectory and capital strategy. Leadership ## The team behind the platform Kathleen Colatrella, RPh, MS Founder & President Founded LINEA System in 2008. Background includes senior clinical research and medical affairs roles at Roche, Genta, and MannKind. Nathan Lin Head of Engineering & Data Leads engineering and data at LINEA System, building the Research Site Index and AcceleTrial end to end, from the site-scoring engine and data pipelines to security and multi-language support. Kaitlin Kumar, MD, PhD Medical Research Analyst Physician-scientist leading peer-to-peer outreach to investigators and sites. Brings clinical credibility to feasibility and turns protocol requirements into the conversations that surface the right sites. Elsida Mazariegos Operations Consultant Supports operations at LINEA System, keeping sponsor engagements organized and on track from site selection through activation. Alex Colatrella Financial Advisor Advises on finance and growth strategy, helping LINEA scale sustainably as adoption expands. Get in Touch ## Ready to work together? Request a demo or reach out directly to learn how AcceleTrial can accelerate your next trial. [Request a Demo](https://www.lineasystem.com/contact/)[kcolatrella@lineasystem.com](#) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/about/* ======================================================================== # AcceleTrial **Source:** [https://www.lineasystem.com/acceletrial/](https://www.lineasystem.com/acceletrial/) **Published:** April 6, 2026 --- What AcceleTrial Does ## Site selection to activation,fully governed Study startup is fragmented by design: contracts in email, milestones in spreadsheets, documents in shared drives. AcceleTrial replaces all of it with a single governed workspace. Every action is tracked, every milestone is visible, and every delay is flagged before it becomes a problem. [See It in Action](https://www.lineasystem.com/contact/) AcceleTrial® | Study Startup Dashboard Phase III Oncology · 8 sites SiteContractRegulatoryStatus Academic medical center, Midwest USPrincipal investigator A Executed Complete Active University health system, Mid-Atlantic USPrincipal investigator B Executed In Progress Pre-Activation Teaching hospital, Northeast USPrincipal investigator C Pending Pending Qualifying NCI-designated cancer center, South USPrincipal investigator D In Review Complete SLA Risk 3 Active 2 Pending 1 SLA Risk Day 18 Current Day The AcceleTrial Workflow ## Every stage. One platform. 01 Site Selection Ingest protocol. AI extracts parameters and ranks sites instantly. Upload your protocol document and AcceleTrial's AI extracts therapeutic area, indication, phase, and enrollment targets automatically, then scores and ranks the full RSI against your protocol in real time. Your ranked site list loads directly into the startup workspace. No manual entry, no spreadsheets. 02 Qualification Qualify and approve sites through an auditable workflow Each site moves through a structured qualification workflow. Sponsors and CROs review RSI scores, feasibility responses, and capacity data, with every approval or rejection logged by timestamp and user. No approval chains in email, no decisions that can't be reconstructed. 03 Feasibility Outreach Automated feasibility outreach across your full site list AcceleTrial dispatches digital feasibility questionnaires to every selected site automatically. Responses are collected, scored against your protocol, and ranked in the platform, replacing weeks of manual coordination with days of automated outreach. 04 Contracts & Budgets Manage contract and budget execution in one place Budget negotiations, contract drafts, redlines, and final executed agreements are all managed within AcceleTrial. Milestone-linked budget approvals, payment terms, and amendment tracking give both sponsors and sites full visibility into every deal. 05 Regulatory Documents Centralize essential documents and IRB submissions IRB submissions, protocol amendments, essential document checklists, and regulatory correspondence are stored, versioned, and tracked against submission deadlines. AcceleTrial flags missing documents before they delay startup. 06 Activation Track milestones from SIV through first patient enrolled Site initiation visits, enrollment readiness checks, and activation milestones are tracked in real time across your full site portfolio. AcceleTrial surfaces SLA risks before they impact the timeline, giving your team time to intervene. Platform Capabilities ## Built for how ops teams actually run trials AcceleTrial replaces the tools, email threads, and spreadsheets that clinical operations teams use today with a single governed workspace designed for the complexity of multi-site study startup. Role-Based Workspaces Sponsor, CRO, and site teams each see a workspace tailored to their role and access level. Document visibility, approval authority, and reporting views are governed by role, not by who was CC'd on the last email. Document Controls & Audit Trail Every document version is tracked, every approval action is logged with timestamp and user. The complete audit trail is available for regulatory review at any point in the study, not reconstructed after the fact. SLA Monitoring & Risk Flags AcceleTrial tracks every contractual and regulatory milestone against its deadline. Sites that are falling behind are automatically flagged, giving your team advance warning before a delay becomes a timeline risk. Portfolio Reporting & Visibility Study startup status across all sites is visible in a single dashboard: contract progress, regulatory completeness, activation readiness, and enrollment projections. No more assembling weekly status updates from site coordinators. Get Started ## See AcceleTrialwith your protocol Request a demo and we will walk you through a live session using your therapeutic area, indication, and site portfolio size. [Request a Demo](https://www.lineasystem.com/contact/)[Explore the RSI](https://www.lineasystem.com/rsi/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/acceletrial/* ======================================================================== # ACS Case Study **Source:** [https://www.lineasystem.com/case-study-acs/](https://www.lineasystem.com/case-study-acs/) **Published:** April 16, 2026 --- The Challenge ## A large cardiovascular site network.With no room for slow document cycles. Identifying and qualifying 60 clinical sites for an Acute Coronary Syndrome study required both volume and speed. Standard feasibility workflows would not meet the sponsor's activation timeline. 01 Identifying 60 sites for a cardiovascular LDL-lowering drug trial The sponsor needed 60 clinical sites with cardiovascular expertise, patient access, and operational readiness for an ACS study involving an innovative LDL-lowering drug. 02 Acquiring CDAs and Feasibility Questionnaires under compression Communicating with a large number of clinical sites and executing CDAs and Feasibility Questionnaires within a compressed schedule required platform-level automation. 03 Timely site activation to accelerate trial timelines Sites needed to be activated in a timely fashion to accelerate the overall trial timeline. Activation delays at any site created scheduling risk for the study as a whole. The Solution ## 65 cardiovascular sites.2 to 3 days to feasibility. Using AcceleTrial, LINEA System identified 65 sites with the cardiovascular trial expertise and patient access required. Turnaround time for feasibility assessments and CDAs was 2 to 3 days, exceeding the sponsor's expectations. All necessary study documents were collected at 50% the standard timeline through AcceleTrial's automated document workflow. Sites were evaluated against a rigorous set of qualification criteria ensuring each site was operationally ready. Site Qualification Criteria Cardiovascular Clinical ExperienceTrial HistoryCOVID-ReadinessDebarment CheckPatient Access AcceleTrial® | ACS Study Performance 65 **Sites Identified**Cardiovascular sites exceeding the target of 60 2-3 **Days to Feasibility and CDAs**Turnaround exceeded the sponsor's expectations 50% **Faster Document Collection**All study documents at half the standard timeline 46 **Sites Selected**46 LINEA sites selected and included in the ACS study Outcomes ## Expectations exceeded.On every metric. 65 Sites Identified 65 cardiovascular sites identified against a sponsor target of 60, all evaluated against protocol-specific criteria. 2-3 Days Feasibility Turnaround Feasibility and CDAs completed in 2 to 3 days through AcceleTrial's automated workflow, exceeding sponsor expectations. 50% Faster Document Collection All necessary study documents collected at 50% the standard timeline, eliminating the manual coordination bottleneck. 46 Sites Selected 46 LINEA-sourced sites selected and included in the ACS study, with additional sites available in reserve. Get the Full Story ## Download the case studyor see AcceleTrial live Get the one-page PDF summary or request a personalized demo using your protocol and therapeutic area. [Download One-Page Summary](https://www.lineasystem.com/case-study-acs-summary/?auto=1) [Request a Demo](https://www.lineasystem.com/contact/) [All Case Studies](https://www.lineasystem.com/resources/#case-studies) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/case-study-acs/* ======================================================================== # ACS Case Study Summary **Source:** [https://www.lineasystem.com/case-study-acs-summary/](https://www.lineasystem.com/case-study-acs-summary/) **Published:** April 16, 2026 --- Save as PDF Case Study | Acute Coronary Syndrome 65 cardiovascular sites. *2 to 3 days to feasibility.* How AcceleTrial compressed feasibility timelines for a global ACS trial with an innovative LDL-lowering drug, exceeding the sponsor's site targets and turnaround expectations. 65 Sites Identified 2-3 Days Feasibility Turnaround 46 Sites Selected 50% Faster Documents The Challenge ### 60 cardiovascular sites for LDL-lowering drug trial Identifying sites with cardiovascular expertise, patient access, and operational readiness for an ACS study. ### Acquiring CDAs and FQs under compression Communicating with a large number of sites and executing study documents within a compressed schedule. ### Timely activation to accelerate trial timeline Activating sites quickly to prevent downstream delays in the overall study schedule. The Solution Using AcceleTrial, LINEA identified 65 sites with cardiovascular trial expertise. Feasibility and CDAs were completed in 2 to 3 days, exceeding the sponsor's expectations. All documents were collected at 50% the standard rate. Sites were evaluated against trial history, COVID-readiness, debarment, and clinical experience. Site Criteria Cardiovascular Clinical ExperienceTrial HistoryCOVID-ReadinessDebarment CheckPatient Access Outcomes ### 65 Sites Identified Exceeded sponsor target of 60, with full qualification against cardiovascular protocol criteria. ### 2-3 Day Turnaround Feasibility and CDAs completed in 2 to 3 days, exceeding the sponsor's stated expectations. ### 46 Sites Selected 46 LINEA sites selected for inclusion in the ACS study. LINEA System · AcceleTrial® kcolatrella@lineasystem.com lineasystem.com --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/case-study-acs-summary/* ======================================================================== # AI Blueprint **Source:** [https://www.lineasystem.com/ai-blueprint/](https://www.lineasystem.com/ai-blueprint/) **Published:** July 18, 2026 --- 01 Audit Assess and realign existing processes 02 Activate Turn data into actionable insights 03 Accelerate Drive speed without losing precision 04 Amplify Scale learnings across programs 05 Augment Empower people with intelligent support 01 Stage 01 Audit: Assess and Realign Examine how work truly happens today and uncover where effort, time, or data are being lost. 01 Map Actual Workflows Document how work truly happens, not how the SOP says it should. 02 Surface Hidden Friction Identify delays, manual loops, handoffs, and duplicated effort. 03 Quantify Impact Measure where time, cost, and quality are most affected. 04 Define Failure Modes Capture where errors, variability, or bottlenecks occur most often. 02 Stage 02 Activate: Focus and Define Translate insights into a clear direction, setting the purpose, data needs, and decision boundaries for the work ahead. 01 Clarify Desired Outcomes Decide what better looks like in measurable, operational terms. 02 Set Decision Boundaries Define which choices can be automated without risk and which require a human touch. 03 Establish Data Foundations Identify the minimum viable data needed to power safe, reliable AI. 04 Prioritize High-Leverage Moments Choose the specific workflow points where AI can meaningfully improve speed or quality. 03 Stage 03 Accelerate: Speed with Precision Use automation to streamline execution while preserving quality and compliance. 01 Streamline Critical Steps Remove repeat work and manual handoffs so high-value tasks move forward without friction. 02 Automate the Predictable Let systems handle recurring, rules-based activities so teams can focus on judgment and strategy. 03 Shorten Decision Cycles Reduce the time between insight and action by delivering the right information at the moment it matters. 04 Strengthen Quality Controls Embed validation and traceability into every accelerated workflow so speed never compromises oversight. 04 Stage 04 Amplify: Scale What Works Turn individual wins into organizational capability by sharing learnings, datasets, and improvements across teams. 01 Reuse Proven Inputs Turn data, logic, and templates from earlier work into shared assets that strengthen every new project. 02 Standardize What Matters Create repeatable structures for quality, compliance, and oversight so teams are not reinventing core processes. 03 Push Insights Across Programs Make learnings from one study or workflow available to all others, reducing blind spots and improving consistency. 04 Elevate Organizational Memory Ensure knowledge does not vanish when a project ends by encoding it into systems that learn over time. 05 Stage 05 Augment: Empower with Intelligence Enhance human decision-making by delivering relevant information, predictions, and guidance at the exact moment of need. 01 Surface Actionable Intelligence Give teams context, predictions, and risk signals at the exact moment they are needed, not buried in another dashboard. 02 Guide Decisions, Not Replace Them Enable humans to move faster and with more confidence by providing guardrails, not overrides. 03 Adapt to Real-Time Feedback Let systems learn from outcomes, course-correct in flight, and refine recommendations as more data accumulates. 04 Enhance Every Role Equip clinicians, operations teams, vendors, and sponsors with tools that reduce cognitive load and amplify collective judgment. Putting the Blueprint to Work ## A continuous loop,not a one-time project. The Blueprint is not a one-time project. It is a continuous loop: audit, activate, accelerate, amplify, and augment, then begin again as the work evolves. Sponsors, CROs, and research organizations that treat intelligent operations as a discipline, not a tool, compound their advantage with every study. **Want to put the Blueprint to work?** Talk to us about where AI can move the needle for your operations. Get the Full Blueprint ## Download the PDFor see AcceleTrial live Take the full framework with you or request a personalized demo to see how AcceleTrial applies AI across the operational lifecycle. [Download the AI Blueprint PDF](https://www.lineasystem.com/wp-content/uploads/playbooks/ai-blueprint.pdf) [Request a Demo](https://www.lineasystem.com/contact/) [All Resources](https://www.lineasystem.com/resources/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/ai-blueprint/* ======================================================================== # AI Integration Playbook **Source:** [https://www.lineasystem.com/playbook-ai/](https://www.lineasystem.com/playbook-ai/) **Published:** April 17, 2026 --- 01 Step 1 Align on Vision and Readiness Establish organizational clarity, governance, and readiness for AI adoption. 01 Convene an AI Steering Committee Form a multidisciplinary working group that includes clinical operations, IT, compliance, and data science leaders to set the strategy. 02 Conduct an AI Usage and Readiness Assessment Survey team members to identify current AI usage patterns and awareness levels. Evaluate IT infrastructure, data availability, and staff competency. 03 Define Governance Policies Establish policies that promote secure and responsible AI use, particularly when handling patient data. Decide whether generative tools like ChatGPT are permitted for tasks like safety summaries or internal documents. 02 Step 2 Identify High-Impact, Low-Risk Use Cases Start with practical, non-disruptive applications of AI that yield measurable wins. 01 Consistency Checks and Document QA Use AI to cross-verify protocol consistency, detect discrepancies between endpoints and data collection methods, and ensure alignment with regulatory standards. 02 Protocol and Document Drafting Automate the generation of technical content including protocols, lay summaries, and trial brochures with AI-assisted drafting tools. 03 Feasibility Questionnaire Automation Prepopulate site demographics using AI, reducing site burden and improving response quality. 04 Chatbots for Patient Engagement Deploy AI-powered chatbots to educate, screen, and retain patients, improving recruitment and satisfaction. 03 Step 3 Design a Pilot Project Demonstrate the value of AI with a targeted, measurable pilot. 01 Select a Workflow for the Pilot Start with site selection using ML models to predict site performance and access to patient populations. 02 Define Success Metrics Track time-to-site-activation, protocol deviation rates, patient dropout rates, or recruitment cycle time. 03 Choose the Right Tool Select whether to build in-house or partner with vendors. Prioritize long-term efficiency by developing internal capabilities where possible. 04 Train the Team Provide hands-on exposure and sandbox environments. Appoint an internal AI champion for cultural adoption. 04 Step 4 Monitor, Learn, and Iterate Ensure pilot success, refine your approach, and build stakeholder confidence. 01 Monitor Performance Closely Evaluate hallucinations, error rates, and user feedback. Validate outputs manually in early phases before expanding scope. 02 Document Learnings Record what worked and what failed. Encourage transparency to build institutional memory and support future decisions. 03 Adjust Policies and Expand Scope Use pilot learnings to update governance policies and expand AI applications into additional clinical workflows. 05 Step 5 Scale and Integrate Strategically Build a unified, enterprise-wide approach to AI in clinical operations. 01 Site Activation and Investigator Training Automate regulatory document collection, staff training personalization, and logistics tracking at scale. 02 Data Validation and Safety Monitoring Use AI for real-time monitoring, fraud detection, and digital twin simulation for patient outcomes. 03 Regulatory Submissions and CSR Drafting Apply natural language processing to draft Clinical Study Reports, maintain formatting compliance, and ensure clarity. 04 Supply Chain Optimization Use predictive AI for drug forecasting, shipment tracking, and demand modeling across the trial lifecycle. Final Recommendations ## Principles for thelong haul. 01 Centralize AI Oversight Avoid fragmented AI deployments. Build a roadmap just as you would for clinical systems integration to ensure coherence across the organization. 02 Stay Human-Centric Use AI to augment, not replace, clinical judgment and patient engagement. Be intentional in how AI tools empower your team. 03 Continue the Dialogue Clinical trials are evolving rapidly. Reassess use cases quarterly, and adapt your strategy accordingly. Get the Full Playbook ## Download the PDFor see AcceleTrial live Take the full framework with you or request a personalized demo to see how AcceleTrial applies AI to site identification and activation. [Download the Playbook PDF](https://www.lineasystem.com/wp-content/uploads/playbooks/ai-clinical-trials-playbook.pdf) [Request a Demo](https://www.lineasystem.com/contact/) [All Resources](https://www.lineasystem.com/resources/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/playbook-ai/* ======================================================================== # Clinical Intelligence Briefing **Source:** [https://www.lineasystem.com/briefing/](https://www.lineasystem.com/briefing/) **Published:** April 24, 2026 --- The # Clinical Signal AI & Clinical Trials, Curated  ·  Weekly Dispatch Vol. I · No. 41 October 11, 2026 Est. 2026 From the Editor ## Biotech sector faces mounting pressures as clinical setbacks and funding challenges drive consolidation The week of October 11, 2026 brought a wave of clinical disappointments and strategic pivots across the biopharma landscape. Argenx's Sjögren's failure and Revolution's FDA concerns triggered sharp sell-offs, while Caribou's funding struggles exemplify the difficult environment forcing companies toward mergers and strategic alternatives. Against this backdrop, regulatory actions and dealmaking activity signal an industry in transition. Clinical Setbacks and Market Reactions Argenx falls as Sjögren's setback offsets celiac drug progress A monitoring board recommended stopping Argenx's Vyvgart study in Sjögren's syndrome for futility, surprising Wall Street and eliminating another blockbuster expansion opportunity. The setback overshadowed positive progress in the company's celiac disease program. via [BioPharma Dive](https://www.biopharmadive.com/news/argenx-sjogrens-vyvgart-celiac-forte-study-results/832463/) FDA review docs spark Revolution sell-off; Zealand diabetes data underwhelm analysts New FDA disclosures suggested Revolution's Rasonque might not be as broadly effective as previously thought, triggering a market sell-off. The news contributed to broader concerns about clinical execution across the sector. via [BioPharma Dive](https://www.biopharmadive.com/news/rasonque-fda-zealand-tukysa-ultragenyx-tcgx-china/832492/) Popular Longevity Supplement Fails to Meet Endpoint in Parkinson's Trial A widely used longevity supplement failed to achieve its primary endpoint in a Parkinson's disease clinical trial, adding to the week's string of clinical disappointments. via [MedPage Today](https://www.medpagetoday.com/neurology/parkinsonsdisease/123349) Funding Pressures and Strategic Shifts Caribou to halt CAR-T work, lay off staff amid 'challenging' funding climate Despite having an allogeneic cell therapy ready for late-stage lymphoma testing, Caribou could not secure funding to support the effort and will pursue strategic alternatives. The company's struggles exemplify the difficult financing environment facing biotech developers. via [BioPharma Dive](https://www.biopharmadive.com/news/caribou-layoffs-strategic-alternatives-allogeneic-cell-therapy-vispacel/832343/) In the hunt for reverse merger targets, Caribou could be prized game The struggling cell therapy developer's exploration of strategic alternatives makes it a likely candidate for reverse merger interest. Caribou's characteristics position it as attractive game in the current consolidation environment. via [BioPharma Dive](https://www.biopharmadive.com/news/caribou-reverse-merger-prospects-cell-therapy-private-public/832494/) This week in charts: What's driving biotech's recent pullback? BioPharma Dive's data visualization examines factors pressuring biotech stocks recently and documents the frenetic pace of startup buyouts this year. The analysis provides context for understanding current market dynamics. via [BioPharma Dive](https://www.biopharmadive.com/news/biotech-charts-xbi-private-public-merger-acquisition-deals/832398/) Deals and Capital Markets Viatris boosts pain drug portfolio with $1.7B buyout of Pacira The deal gives Viatris two non-opioid pain treatments that generated nearly $700 million in 2025 but could soon lose patent protection. Viatris pledged to use its intellectual property expertise to sustain sales. via [BioPharma Dive](https://www.biopharmadive.com/news/viatris-pacira-acquire-pain-drug-zilretto-exparel/832481/) TRex Bio prices $117M IPO to support immune drug work TRex Bio completed a $117 million IPO to advance drugs treating immunological conditions by activating Treg cells. Eli Lilly is the largest equity holder in the company. via [BioPharma Dive](https://www.biopharmadive.com/news/trex-bio-ipo-pricing-autoimmune-tregs/832297/) Regulatory and Policy Developments HHS launches new plan to strengthen vaccine injury research, reporting Spearheaded by Robert F. Kennedy Jr., the initiative will establish a new NIH clinic, update monitoring systems, and provide reimbursements for doctors who report suspected vaccine side effects. The plan represents a significant policy shift in vaccine safety surveillance. via [BioPharma Dive](https://www.biopharmadive.com/news/hhs-vaccine-injury-reporting-research-rfk/832532/) Halozyme prevails in patent fight with Merck A Dutch court barred Merck from selling subcutaneous Keytruda in several European countries, handing Halozyme a significant patent victory. The ruling has implications for subcutaneous formulation strategies across the industry. via [BioPharma Dive](https://www.biopharmadive.com/news/halozyme-merck-europe-enliven-insmed-rougetx-kymathera/832282/) “ Editor's Takeaway Clinical trial sponsors face a challenging environment marked by high-profile study failures and constrained capital, driving increased M&A activity and strategic repositioning. The convergence of clinical execution risks and funding pressures underscores the importance of robust trial design and flexible strategic planning. The Clinical Signal Published by [LINEA System](https://lineasystem.com)  ·  Curated weekly from public industry sources  ·  Not investment advice Issue published October 11, 2026  •  Next edition next week  •  Sources linked within each item --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/briefing/* ======================================================================== # Common Questions Guide for AcceleTrial **Source:** [https://www.lineasystem.com/guide-acceletrial-faq/](https://www.lineasystem.com/guide-acceletrial-faq/) **Published:** April 17, 2026 --- See It in Action ## Ready to put AcceleTrialto work on your next study? Our team will walk you through the AcceleTrial workflow using a study profile matched to your therapeutic area and target geography. No generic demos. [Request a Demo](https://www.lineasystem.com/contact/) [Explore AcceleTrial](https://www.lineasystem.com/acceletrial/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/guide-acceletrial-faq/* ======================================================================== # Contact **Source:** [https://www.lineasystem.com/contact/](https://www.lineasystem.com/contact/) **Published:** April 6, 2026 --- Request a Demo Fill out the form and we will be in touch within one business day to schedule your session. First Name * Last Name * Work Email * Company * Your Role * Select role Clinical Operations Site Selection CRA / Clinical Monitor CRO / Vendor Business Development Executive Leadership Other Therapeutic Area * Select area Oncology Cardiology Neurology Immunology Rare Disease Infectious Disease Endocrinology Other Tell us about your program (optional) Request Demo We will never share your information. By submitting you agree to our [Privacy Policy](/privacy-policy/). ✓ Request received We will be in touch within one business day to schedule your session. What to Expect ## A focused sessionbuilt around your trial Every demo uses your therapeutic area and protocol parameters, not generic examples. You will see real site rankings, real RSI data, and the actual workflow your team would use. What Happens Next 1 **We review your submission** and match you with the right team member for your therapeutic area. 2 **We reach out within one business day** to schedule a 45-minute session at a time that works for your team. 3 **Your live session** covers site scoring for your indication, the RSI data behind the rankings, and the full activation workflow. 4 **Follow-up materials** including a sample site ranking list for your indication are sent within 24 hours of the session. Direct Contact Kathleen Colatrella, RPh, MS Founder & President, LINEA System [kcolatrella@lineasystem.com](#) 140 Littleton Rd., Suite 305 Parsippany, NJ 07054 45 min Typical Demo Length 1 day Response Time Live Data Real RSI Site Rankings --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/contact/* ======================================================================== # GlobalData Conducts Comprehensive Survey of Clinical Professionals **Source:** [https://www.lineasystem.com/2021/01/15/globaldata-conducts-comprehensive-survey-of-clinical-professionals/](https://www.lineasystem.com/2021/01/15/globaldata-conducts-comprehensive-survey-of-clinical-professionals/) **Published:** January 15, 2021 --- By Sarah Hof Countless aspects of clinical trial operations have been disrupted in the last 10 months. To explore new pain points and shifts in trial planning across the industry as a result of the pandemic, GlobalData conducted a survey to gather metrics from professionals across the world, as reported by [Pharmaceutical Technology](https://www.pharmaceutical-technology.com/). Overall, GlobalData found that patient recruitment was the most significant challenge to clinical teams across the world. Over 20% of all respondents from each region (North America, Asia Pacific (APAC), Europe and Rest of World (RoW)) reported that patient recruitment due to safety concerns was the biggest challenge they face, with nearly a third (32%) of all APAC participants saying so.  A significant portion of respondents noted that the pandemic was forcing them to cancel or delay their studies. Nine percent of APAC participants, 16% of European participants, 21% of North American participants, and 22% of the participants from RoW reported as such.  You can read the full article and see all survey results [here](https://www.pharmaceutical-technology.com/surveys/covid-19-effect-patient-recruitment-most-affected-in-clinical-trial-planning-across-regions/).  --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2021/01/15/globaldata-conducts-comprehensive-survey-of-clinical-professionals/* ======================================================================== # How modern healthcare service providers can leverage smart tech for enhanced efficacy **Source:** [https://www.lineasystem.com/2020/12/09/how-modern-healthcare-service-providers-can-leverage-smart-tech-for-enhanced-efficacy/](https://www.lineasystem.com/2020/12/09/how-modern-healthcare-service-providers-can-leverage-smart-tech-for-enhanced-efficacy/) **Published:** December 9, 2020 --- Source: By Sumana Iyengar, CEO and Co-Founder of Goavega   [(Health Vision)](https://healthvision.in/modern-healthcare-service-providers-can-leverage-smart-tech-for-enhanced-efficacy/) — In current challenging times of pandemic, technology has proved to be a vital lifesaver for several industries, including healthcare. With social distancing norms, a series of essential services have moved to the online platform to serve their consumers better, while avoiding physical contact. Healthcare has been one of the most crucial ones among these. While health technology has rapidly evolved over the past decade, it was limited to specific disease/ wellness plans or concentrated around patient treatment. The pandemic has allowed for the role of technology to go beyond the individual patient wellness and moved to the overall ‘digitisation’ of healthcare services – a vital step in the growth of B2B health tech. As per a report titled ‘Digital healthcare market in India 2019’, the sector was valued at INR 116.61Bn in 2018, and is estimated to reach INR 485.43 Bn by 2024, growing at a CAGR of~27.41% during the 2019-2024 period. However, areas around digitisation of data, large scale adoption by hospitals etc., continue to remain slow. In order to ensure a uniform and seamless healthcare technology, that can be a major enabler for the country, is in place, the following areas of technology adoption need to be explored:  1. **Clinical Registry:** This is one area that needs immediate attention. Supported by positive government policies that work towards digitisation of health data across the country, tech providers can work towards creating customised solutions that can promote seamless exchange of credible healthcare data. The storage of integrated patient record can be useful incase of consultation with a different specialist, irrespective of the geographical boundaries. Further, it can allow data collection from multiple sources, put it in a common format and upload it into the system in an easily accessible manner. Data collection, management, and analytics can go a very long way in not just streamlining treatment but also in preventive healthcare, identifying disease patterns related to deficiencies or external pollutants or even help map and control the spread of an epidemic. On a hospital level, Clinical registry of patients can help easy paperless storage and quick access of data that can help reduce turn-around time for treatments and assist doctors to make quick and effective decisions. 2. **Integrated Online Consultation: ** Online consultation has also proved to be of particular significance during these trying times of a contagious pandemic. However, an increasing number of patient-doctor engagement has been happening on generalised platforms like zoom, skype, google meet or whatsapp video calls, and while it is functional, there is a lot of potential for exploring integrated online consultation technology solutions. According to https://www.itransition.com/, the global market share of tele-health is expected to dramatically increase from $38.3 billion in 2018 to over $130.5 billion by 2025. Hospitals can rely on integrated online consultations for end to end patient engagement, including third party coordination and management. From scheduling appointments, receiving prescriptions, and accessing online history of patients to having access to external investigation reports, scheduling blood tests and having reports directly sent to the doctor, the solution can help hasten the procedure, create transparency and credibility while enhancing patient comfort as they do not need to physically visit the doctor with files of medical data.  3. **Mobile Health/ SaaS:** Personalised wellness apps on smart phones have been gaining popularity during the lockdown, with people relying on them for daily exercise, yoga, diet and even sleep and water reminders. However, specialised healthcare apps that offer individual consultation and monitoring of patients, can be significant in case of elderly care, and in the wellness of patients with pre-disposed or serious medical conditions. Digital channels of healthcare allow facilities and patients to maintain contact remotely, and encourage daily/ fortnightly monitoring, easy payments, and check-up reminders etc., which can be programmed on a personalised level. Technology of IoMT (Internet of Medical things) can also provide patient care, especially in case of implanted devices like pacemakers etc.  4. **Hospital management –** Digitisation of hospital management can go a long way in creating cost-effective, seamless, and efficient operations. Automation that can help across segments, from staff schedules and management, OT schedules, specialist visits, third party coordination, including vendors and partners like laboratories, insurance companies etc., to even monitoring and surveillance of hospital premises. Through integrated CCTV cameras, social distancing and mask protocols can be monitored, Critical care rooms and patient movement can be supervised while facial recognition and biometric attendance for staff can be linked with payroll management and account systems.  5. **Tech solutions for Pharma: **While a lot of innovation in treatment and medical welfare is carried out by pharma companies, adopting technology for operations, data management, and analytics and also for identifying counterfeit batches, has a huge potential. Counterfeit medicines are not only dangerous for patient health but also pose an expensive problem for the pharma sector. Leveraging block-chain, pharma manufacturers can identify and report these fraudulent products and help arrest their spread. Apart from this, recording and storing data around clinical trials, monitoring the progress of new innovations and even collaborating with international scientists, patenting technology and monitoring correct use of drugs, etc., technology adoption can help boost the efficacy and transparency in the pharma sector. While the above offer a broader perspective to digital adoption, customisation based on socio-economic, demographic and critical care conditions is the way forward for B2B healthcare tech adoption. Further, by collaborating with the numerous Tech and SaaS service providers across the country, hospitals and other medical institutes can easily avail cost effective, customised, and efficient digital infrastructure to suit their specific requirements. While we continue to march ahead with its ‘Digital india’, ‘Cashless economy’ and centralised registry of citizens, healthcare technology on a national scale will be the determining factor to ensure a healthier and robust population.  --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2020/12/09/how-modern-healthcare-service-providers-can-leverage-smart-tech-for-enhanced-efficacy/* ======================================================================== # Lack of Diversity in Clinical Trials – How Sponsors Are Planning to Increase Representation **Source:** [https://www.lineasystem.com/2021/02/09/lack-of-diversity-in-clinical-trials-how-sponsors-are-planning-to-increase-representation/](https://www.lineasystem.com/2021/02/09/lack-of-diversity-in-clinical-trials-how-sponsors-are-planning-to-increase-representation/) **Published:** February 9, 2021 --- By Karen Ledesma Diversity and inclusion are imperative pieces when conducting clinical trials, but they continue to fall short at representing the diverse population. Factors such as differences in age, ethnicity, race, and gender may yield distinctive results in people when responding to the same treatment. When including a diverse population, one will be able to see where results may or may not be effective or safe in certain populations. Inclusion of all these groups is paramount as it provides findings that are more generalizable to the whole population. When all diverse populations are included, it will validate that the drug or medical device is efficacious and safe for all and not just for one population. Specific groups have been underrepresented for many years in clinical trials, especially people of color. For instance, in an article[from JAMA oncology](https://jamanetwork.com/journals/jamaoncology/fullarticle/2748395), it was found that only 145 trials of 230 reported any information about the participants’ race for FDA oncology drug approvals. According to the same article, Whites represented 76.3%, Asians 18.3%, Blacks 3.1%, and Hispanics 6.1% of trial participants and from 2013 the proportion for each race enrolled changed minimally with the Black participants enrollment decreasing slightly as Hispanics increased by a little over one percent. Compared with their proportion of US cancer incidence, Blacks and Hispanics continue to be underrepresented, while Asians are overrepresented, and Whites are represented correctly. According to an article posted in[PharmaVoice](https://www.pharmavoice.com/article/2018-03-diversity/), African Americans account for 13% of the US population, but only make up 5% of clinical trial participants and Hispanics account for 16% of the US population, but only make up 1% of clinical trial participants. On the other hand, Caucasians account for 67% of the population and 83% of research participants. Additionally,[PharmaVoice](https://www.pharmavoice.com/article/2018-03-diversity/) mentioned Census Bureau’s prediction that racial and ethnic minority populations in the United Stated will grow to become half of the U.S population in three decades, by 2050. As a result of the increase in the minority populations, it is expected that clinical trial studies will begin to include participants of all races to better represent the population at large.  **Strategies sponsors are considering to increase representation** Although the importance of diversity and inclusion has been known to sponsors, not much has been done to increase the representation of minorities. There are many approaches sponsors can take to guarantee that the study population better reflects the entire population who will be administered the new treatment. Dr. Jonathan Loree, a Medical Oncologist and Assistant Professor at the University of British Columbia, told[Medical New Today](https://www.medicalnewstoday.com/articles/increasing-diversity-in-clinical-trials-what-can-doctors-regulators-and-patients-do#Who-can-drive-long-lasting-change?) (MNT) that  “ need to listen to patients and understand how they feel about research and the barriers each patient faces to participating in clinical studies.” Communication between physicians and patients plays a crucial component in clinical studies. it will help physicians better understand their patients as well as their concerns and challenges they face. Another important aspect is including the patient’s voice during the planning of clinical trials. Dr. Kanwal Raghav, an Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, communicated to MNT that patients themselves can influence the demographics of future trials by “regularly inquiring about their possibilities of participating in clinical trials.” Furthermore, he mentioned that researchers should “educate patients on how researchers design and run trials and involve them to help develop strategies to reach more diverse populations.” Additionally, Rear Admiral, Richardae Araojo stated “identifying site locations where there are more racial and ethnic minorities and diverse study team staff are also efforts that support recruiting minority populations.” A site having diverse staff, researchers, investigators, and sponsors can most certainly increase the amount of minority participants by virtue of availability of studies in these areas. The Food and Drug Administration has been working on practices that will lead clinical trials to better reflect the whole population. The FDA has been “hosting public meetings, developing tools, and issuing guidance documents” said RADM Araojo. Araojo also indicated that the FDA’s Office of Minority Health and Health Equity is working towards more cultural and linguistic strategies and resources. These include campaigns, educational material, public service announcements, and social media programs to raise awareness on the need for minority groups to participate in clinical trials in both English and Spanish. **What sponsors can do to increase representation** Sponsors play an enormous role in helping to increase diversity in clinical trials. Dr. Coleman Obasaju, a Global Leader for Clinical Diversity at Eli Lilly and Company, wrote in PharmaVoice.  A forum called diverse site centers of excellence was created and serves as a means for them to “reach out to stakeholders to have productive discussions around tactics that can be scaled up to have a bigger impact in the country.” This forum will help them collaborate with other pharma companies and groups as an effort to increase diversity in clinical trials. In 2016, [Biogen](https://www.biogen.com/en_us/stories/tufts-clinical-trial.html) launched MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions), a network of healthcare practitioners and neurologists to gather data from 17,000 patients from more than 50,000 patient visits to allow a 360-degree disease assessment. Recently, Biogen did a study with Tufts Center for the Study of Drug Development to investigate ways to help improve clinical trials and how to remove barriers that potential participants face in joining. Similar to the actions of the FDA, Biogen is also forming a Community Advisory Board consisting of African Americans and Latino members to help develop educational materials for the minority population. Additionally, Biogen is creating a diversity and cultural sensitivity training to help clinical trials expand the inclusion of diverse populations.   Another solution to increase diversity, as Hopkins Biotech Network suggests, is to implement “mobile health (mHealth) applications and flexible trial design to promote trial diversity.” Hopkins says this will reduce the frequency of study visits and make patients more amenable to financial reimbursement for participation. Sponsors could also use the app to advertise the description of the study and provide a secure link to enroll in the study. This app may help raise awareness and reach more diverse populations, therefore, ensuring that participants in clinical trials do in fact represent the whole population. Using technology and software systems analytics, as LINEA System is improving on, will pave the way to launch clinical trials efficiently and accurately representing a more diverse population to support research and development of a new drug.    --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2021/02/09/lack-of-diversity-in-clinical-trials-how-sponsors-are-planning-to-increase-representation/* ======================================================================== # LINEA System is Officially Certified as a Minority/Woman-Owned Business Enterprise **Source:** [https://www.lineasystem.com/2021/01/20/linea-system-is-officially-certified-as-a-minority-woman-owned-business-enterprise/](https://www.lineasystem.com/2021/01/20/linea-system-is-officially-certified-as-a-minority-woman-owned-business-enterprise/) **Published:** January 20, 2021 --- PARSIPPANY, NJ — LINEA System, a leader in accelerating clinical study start-up, announced today that it has been certified as a Minority/Women-Owned Business Enterprise (MWBE) by the State of New Jersey.  “Earning our Minority/Women-Owned Business Enterprise certification is representative of the values and standards we hold ourselves to, and of those to which we hold vendors and partners.” says Leticia Bidó, VP, Client Success & Strategic Operations at LINEA System. “We are excited to be able to strengthen the supply chain and open up new opportunities with clients who are committed to supporting supplier diversity.” LINEA System, and businesses from all industries who have been certified, can be found on the New Jersey Selective Assistance Vendor Information (NJSAVI) database by searching [here](https://www20.state.nj.us/TYTR_SAVI/vendorSearch.jsp).  ###  **About LINEA System, LLC** LINEA System, LLC is a leader in accelerating clinical trials by leveraging data and technology in a completely new way. The company specializes in site identification, feasibility assessment, and site activation. LINEA System’s cloud-based Study Start-up System (SSUS), AcceleTrial™, enables teams to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and accelerate patient recruitment. **Press contact:** Sarah Hof *Marketing Associate, LINEA System* shof@lineasystem.com --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2021/01/20/linea-system-is-officially-certified-as-a-minority-woman-owned-business-enterprise/* ======================================================================== # LINEA System teams up with Trial By Fire in fully-integrated partnership **Source:** [https://www.lineasystem.com/2020/07/28/linea-system-teams-up-with-simpletrials-ctms-in-fully-integrated-partnership/](https://www.lineasystem.com/2020/07/28/linea-system-teams-up-with-simpletrials-ctms-in-fully-integrated-partnership/) **Published:** July 28, 2020 ---   PARSIPPANY, NJ and OAKLAND, CA – LINEA System, LLC and Trial By Fire Solutions, LLC have begun a partnership to offer their clinical trial solutions, AcceleTrial™ and SimpleTrials, respectively, as a fully integrated solution. This partnership will allow sponsors to take advantage of AcceleTrial™’s study start-up benefits to select and activate the right sites, and of SimpleTrial’s robust clinical trial management system (CTMS) capabilities. LINEA System’s Study Start-Up System (SSUS) provides access to a built-in global database of over one hundred thousand objectively-ranked investigators and sites as well as an intuitive and automated workflow to ensure study start-up progresses efficiently. SimpleTrials provides end-to-end study management functionality, including eTMF, electronic visit reports, and site payments, fully validated and available as the industry’s first on-demand subscription based CTMS offering. “Having LINEA System as a partner enables our clients to more effectively identify and qualify sites based on specific criteria” said Nancy Cecchettini, Co-founder and Chief Product Officer of Trial by Fire Solutions. “For more than a decade, we have provided comprehensive CTMS functionality to manage study start-up through closeout and this partnership will enable our clients to quickly move through the site selection and document completion aspects of their studies with one end-to-end service.” The synthesis of LINEA Systems’ and SimpleTrials’ technologies will result in a more seamless execution of clinical trials from beginning to end. When a trial is optimized and proceeds efficiently, vital medicines reach patients who need them most. “The current climate demands that clinical teams approach trials in an advanced way, considering all the hurdles to speed availability of critical treatments to patients” said Kathleen Colatrella, Founder and President of LINEA System. “I’m excited to begin the partnership with SimpleTrials and share the value of an SSMS with more clinical teams, and ultimately, make an impact on how trials are conducted.” Colatrella and Cecchettini are excited to launch their partnership at such a time when efficiency and accuracy of clinical trials are more crucial than ever. ### **About LINEA System, LLC** LINEA System is a leader in helping accelerate clinical trials by leveraging data and automated technology in a completely new way. The company specializes in clinical site and investigator identification, feasibility, and site activation. LINEA System’s cloud-based Study Start-Up System (SSUS), AcceleTrial™, enables sponsors to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and patient recruitment. For more information, visit http://www.lineasystem.com. **About Trial By Fire Solutions, LLC** Trial By Fire Solutions is a global leader in web-based clinical trial management solutions focused on innovative applications to improve planning, execution and tracking of clinical studies. With its SimpleTrials CTMS product, along with an experienced clinical technology team, Trial By Fire Solutions provides affordable eClinical solutions to teams of all sizes. For more information, visit http://www.simpletrials.com. **Press contact:** Sarah Hof Marketing Associate, LINEA System shof@lineasystem.com --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2020/07/28/linea-system-teams-up-with-simpletrials-ctms-in-fully-integrated-partnership/* ======================================================================== # LINEA System, LLC Finishes Founder’s First Bootcamp & is Prepared for Large Scale Growth **Source:** [https://www.lineasystem.com/2022/07/06/job-creators-quest-grant/](https://www.lineasystem.com/2022/07/06/job-creators-quest-grant/) **Published:** July 6, 2022 --- Back in September of 2021, LINEA System LLC, a leader in accelerating clinical trial study start-up, announced that it had been awarded the Founders First Job Creators Quest Grant in Pennsylvania/New Jersey. The Grant consisted of a monetary award as well as a full-tuition scholarship to Founders First’s Bootcamp accelerator program exclusively for diverse founders. The Bootcamp finished in April and culminated with a pitch competition. Learn more about our collaboration with Founders First and the Job Creators Quest Grant. Discover how it has impacted the development and growth of LINEA’s mission to accelerate clinical study start-up. #### The Impact of the Job Creators Grant on LINEA System, LLC The impact of the Job Creators Grant on LINEA has been astonishing. We have been able to prioritize expansion. Our team has grown and the resources of the LINEA team has expanded to further develop the company and the mission to revolutionize clinical trials. As Kathleen Colatrella, CEO and Founder of LINEA System reported with Founders First, “The job creators grant through Founders First has helped us significantly. We were able to actually bring some new sales reps onto the team and put those funds toward training to equip them with the information and the tools that they need to be able to continually get the word out for the awareness of our program and our software.” Not only has the Job Creators Grant provided a pillar to develop our mission financially but also through knowledge. The program provided us a voice and resource to further express our intentions and objectives. Since the program has ended, LINEA has experienced growth and a firmer foundation. As Colatrella stated to Founders First, “We were able to pitch clearly our intentions and projections to three different investment companies and we’ve been invited for a second round for two out of three. We’re looking to secure funds, and I think that Founders First prepared us well to be very clear on what is that we are offering, what is the opportunity for any investor and then how they can partner with us to make this company grow.” For the full article on the collaboration between Founders First and LINEA System Click Here: [https://foundersfirstcdc.org/kathleen-colatrella/](https://foundersfirstcdc.org/kathleen-colatrella/) #### About LINEA System, LLC LINEA System, LLC is a leader in accelerating clinical trials by leveraging data and technology in a completely new way. The company specializes in site identification, feasibility assessment, and site activation. LINEA System’s cloud-based Study Start-up System (SSUS), AcceleTrial™, enables teams to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and accelerate patient recruitment. #### About Founders First CDC Founders First is a community development organization and micro-small business accelerator assisting under-served and under-represented established small businesses. The organization focuses on accelerating the growth of diverse-led businesses. The programs provided guide business owners through the process of achieving accelerated growth through specific tasks and expert coaching. An emphasis is placed on service-based businesses led by women, ethnic minorities, military veterans, and businesses located in low to moderate-income areas. **This post was all about the Job Creators Quest Grant** **Other Posts You May Like…** - [LINEA System is Officially Certified as a Minority/Woman-Owned Business Enterprise](https://www.lineasystem.com/2021/01/20/linea-system-is-officially-certified-as-a-minority-woman-owned-business-enterprise/) - [LINEA System teams up with Trial By Fire in fully-integrated partnership](https://www.lineasystem.com/2020/07/28/linea-system-teams-up-with-simpletrials-ctms-in-fully-integrated-partnership/) - [Why is a Study Start-up Management System the vital tool sponsors need?](https://www.lineasystem.com/2020/07/15/study-start-up-management-system-is-the-vital-tool-sponsors-need/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2022/07/06/job-creators-quest-grant/* ======================================================================== # LINEA System: Advanced Technology for Accelerating Clinical Trial Launch **Source:** [https://www.lineasystem.com/2020/07/14/linea-system-advanced-technology-for-accelerating-clinical-trial-launch/](https://www.lineasystem.com/2020/07/14/linea-system-advanced-technology-for-accelerating-clinical-trial-launch/) **Published:** July 14, 2020 ---   LINEA System is proud to have been recognized by MD Tech Review as a Top eClinical Trial Management Solution Provider for our work to accelerate clinical trials! To read the full story and see the spread, please visit their [website](https://www.mdtechreview.com/vendor/linea-system-advanced-technology-for-accelerating-clinical-trial-launch--cid-102-mid-16.html), or click the PDF below.  **“**AcceleTrial™ identifies sites based on objective data validating therapeutic expertise, clinical trial experience, and access to patients that provides transparency for sponsors in choosing the right site. This model takes the guesswork out of clinical trial site identification and combined with an automated workflow, accelerates clinical trial start-up.” -Kathleen Colatrella, Founder and President   [http://../../../../wp-content/uploads/2020/07/LINEA-System_H.pdf](http://../../../../wp-content/uploads/2020/07/LINEA-System_H.pdf)       --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2020/07/14/linea-system-advanced-technology-for-accelerating-clinical-trial-launch/* ======================================================================== # Measuring Site Selection ROI: A Framework for Clinical Operations Leaders **Source:** [https://www.lineasystem.com/guide-site-selection-roi/](https://www.lineasystem.com/guide-site-selection-roi/) **Published:** April 17, 2026 --- Section 1 ## The Cost of GettingSite Selection Wrong Before you can calculate ROI, you need to quantify the baseline: what does poor site selection actually cost? The data below, drawn from peer-reviewed research and industry benchmarks, establishes the scope of the problem in terms leadership can act on. 86% of clinical trials fail to meet their enrollment timelines, making delayed activation a systemic, not exceptional, outcome. Tufts Center for the Study of Drug Development 11% of investigative sites fail to enroll a single patient, representing fully activated sites that deliver zero return on investment. Tufts Center for the Study of Drug Development 37% of sites underenroll relative to their projections, creating persistent timeline slippage across the network. Tufts Center for the Study of Drug Development $600K – $8M estimated cost per month of Phase III delay to sponsors, depending on therapy area and addressable market. Oncology programs routinely reach the high end of this range. A single quarter of slippage can represent tens of millions in peak-revenue exposure. Industry benchmark, compiled from publicly available clinical trial performance and market data 6–9 mo average site startup time industry-wide from contract execution to first patient screened. Site selection failures, choosing the wrong sites from the outset, directly extend this window. Industry benchmark Section 2 ## The ROI Calculation Framework A four-step method for translating industry benchmarks into a business case specific to your program and organization. 01 Step 1 ### Quantify Your Delay Cost Start with the specific financial exposure for your compound. Not all programs carry the same risk per month, so generic benchmarks are a starting point, not a conclusion. Build your delay cost from three inputs: **Revenue at risk per month:** Estimate peak annual revenue for the compound and divide by 12. A drug expected to generate $1 billion annually represents approximately $83M in monthly peak-revenue exposure for every month the launch is delayed. **Cost per enrolled patient:** Across therapeutic areas, patient-level enrollment costs range from $15,000 to over $50,000 when factoring screening, site burden, and dropout. Sites that underenroll inflate this per-patient cost across your entire trial budget. **Site activation cost × underperforming sites:** Calculate your average cost to activate a site (including CDA, contract, IRB, and startup overhead). Multiply by the number of sites historically delivering zero or below-projection enrollment. That product is direct, recoverable waste. 02 Step 2 ### Benchmark Your Site Performance Compare your historical site performance against the industry standard. The Tufts CSDD benchmark establishes that 37% of sites underenroll relative to projection. Where do your programs land? If your underenrollment rate is above industry average, you have clear room for targeted improvement. If you are at or below 37%, the question becomes: **what would a 10-point improvement mean in practice?** A practical model: if your typical program activates 60 sites and 22 (37%) historically underenroll, reducing that to 16 sites (27%) frees enrollment capacity equivalent to 6 fully productive sites, without increasing your site count or budget. Depending on your cost-per-site activation, that can represent $1.5M to $4M in recovered investment per trial. 03 Step 3 ### Model the Startup Compression Site startup time is a direct multiplier on your delay cost. Industry-wide, the window from contract execution to first patient screened averages 6 to 9 months. LINEA clients typically see 50% or greater reduction in time to site identification, compressing the earliest phase of that window significantly. To model this for your program: **Identify your current baseline** for time-to-identification in months. Then apply a 50% compression estimate to that phase. Multiply the resulting time savings in months by your monthly delay cost (calculated in Step 1). That product is your projected timeline benefit in dollars. For a program with a $2M monthly delay cost and a 3-month identification phase, a 50% compression saves approximately 1.5 months, or **$3M in direct delay-cost avoidance** before any other operational efficiency is counted. 04 Step 4 ### Build the Business Case Leadership presentations succeed when they are framed as **risk mitigation**, not efficiency gains. The distinction matters: efficiency is discretionary; risk management is not. A budget conversation anchored in timeline risk and revenue exposure reaches a different decision-maker than one framed around process improvement. Structure your case around three scenarios: Scenario Site Underenrollment Rate Estimated Delay Exposure Site Activation Waste Status quo (current approach) 37% (industry avg.) Based on your monthly delay cost × estimated slippage months Activation cost × zero-enrolling sites Data-driven site selection Target: <20% Reduced by startup compression × monthly cost Substantially reduced through pre-selection scoring Difference (recoverable value) 15–17 percentage points Program-specific, often $3M–$20M+ Recoverable per trial Section 3 ## What Good Looks Like Performance benchmarks across site selection and activation metrics: industry average, top quartile, and LINEA clients. Metric Industry Average Top Quartile LINEA Clients Site identification time 3–6 months 6–8 weeks 2–4 weeks CDA return rate at 7 days ~30–40% 50–60% 50%+ within 7 days Sites that enroll zero patients 11% <5% Minimized through pre-selection scoring Sites that underenroll vs. projection 37% <20% Reduced through RSI matching Industry Average and Top Quartile figures derived from Tufts Center for the Study of Drug Development research and publicly available clinical operations benchmarking data. LINEA client figures reflect observed outcomes and are subject to program-specific variation. Section 4 ## Making the Case to Leadership The strongest business cases for investment in data-driven site selection share a common structural principle: they lead with risk exposure, not feature descriptions. A VP of Clinical Operations or Head of Site Management presenting to a CFO or Chief Medical Officer needs to anchor the conversation in language that resonates at the executive level (timeline risk, revenue delay, and competitive disadvantage) before shifting to operational efficiency. **Frame as risk mitigation, not tooling.** Leadership teams that fund site selection improvements are not buying software. They are buying a reduction in the probability of a failed enrollment quarter, a regulatory delay, or a phase III trial that requires a protocol amendment. Every dollar invested in front-end site intelligence is an insurance policy against a much larger back-end cost. **Lead with the cost of the status quo.** Before describing what a data-driven approach does, quantify what the current approach costs. Use the framework in Section 2 to attach real numbers to your program, then present the data-driven scenario as the alternative. The delta between the two scenarios is the investment's value, stated in terms leadership already owns. **Use timeline compression as competitive advantage.** In competitive therapeutic areas, the first drug to complete enrollment and submit an NDA holds a structural market-entry advantage. Site selection speed is not just an operational efficiency: it is a competitive variable. Framing startup compression in those terms elevates the conversation from process to strategy. **Anchor cost avoidance, not just cost reduction.** Budget-holders respond more readily to costs that will not be incurred than to costs that will decrease. Structure your business case around cost avoidance: activation dollars not spent on zero-enrolling sites, delay costs not realized due to faster identification, and amendment costs avoided through better site-protocol fit. Sample Talking Points for Leadership Presentations - Industry data shows 37% of sites underenroll relative to projection. Across a 60-site program, that is 22 sites failing to deliver on their enrollment commitments, plus the activation investment already spent on each one. - For a program with $2M in monthly delay cost exposure, every month of startup compression translates directly to recoverable revenue. Our current identification timeline represents several months of exposure we can reduce. - Eleven percent of activated sites enroll zero patients. That is not a site performance problem; it is a selection problem. The cost of selecting better sites upfront is a fraction of the cost of activating the wrong ones. - Competitors who compress site identification to two to four weeks reach first patient screened meaningfully earlier. In this indication, that startup advantage translates to direct delay-cost avoidance per month saved. - This is not a request for a new system. It is a request to stop absorbing the cost of the current one, estimated in delay exposure and activation waste recoverable per trial. See It in Practice ## Put the framework to workwith real program data. Request a demo to see how LINEA's RSI scoring and site intelligence platform applies this framework to your specific indication, geography, and site network. [Request a Demo](https://www.lineasystem.com/contact/) [All Resources](https://www.lineasystem.com/resources/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/guide-site-selection-roi/* ======================================================================== # MS Case Study **Source:** [https://www.lineasystem.com/case-study-ms/](https://www.lineasystem.com/case-study-ms/) **Published:** April 16, 2026 --- The Challenge ## A competitive indication.Compressed timelines. High stakes. The sponsor needed a large, qualified site network in Multiple Sclerosis, one of the most competitive therapeutic areas in clinical development, without sacrificing timeline integrity. 01 Site identification at scale in a crowded TA The sponsor needed 60 interested clinical sites (40 to activate, 20 to hold as backup) in Multiple Sclerosis, a therapeutic area with intense competition for qualified investigators and patient populations. 02 Compressed timelines for CDAs and Feasibility Questionnaires The team needed to communicate with a large volume of clinical sites and execute Confidentiality Disclosure Agreements and Feasibility Questionnaires on an accelerated schedule with no margin for delay. 03 Efficient, rapid site activation Sites needed to be activated efficiently and quickly to meet or exceed the sponsor's targeted timelines. Every delay in activation created downstream risk for the overall trial schedule. The Solution ## AcceleTrial identified76 pre-qualified sites Using AcceleTrial, LINEA System identified 76 pre-qualified clinical sites with specific MS expertise and verified patient access. The platform's workflow automation compressed the document and feasibility cycle to a fraction of the typical timeline. Half of all sites completed both the Confidentiality Disclosure Agreement and Feasibility Questionnaire in under 7 days. The rapid FQ turnaround was the key driver that allowed the team to accelerate site selection and stay ahead of the sponsor's schedule. Site Qualification Criteria MS Clinical ExperienceTrial HistoryPatient AccessSpecific Expertise AcceleTrial® | MS Study Performance 76 **Sites Identified**Pre-qualified with MS expertise and verified patient access 50% **CDAs and FQs Completed Under 7 Days**Half of all sites cleared both documents in under a week 40 **Sites Activated**Full sponsor activation target met from LINEA's delivery 60 **Sites Requested**Target (40 active + 20 backup) exceeded on first delivery Outcomes ## Targets exceeded.Timeline compressed. 76 Sites Identified 76 pre-qualified MS sites delivered against a sponsor target of 60, providing both the full activation cohort and a strong backup pool. 50% CDAs and FQs Under 7 Days Half of all sites completed both the CDA and Feasibility Questionnaire within 7 days, materially compressing the site selection cycle. 40 Sites Selected The sponsor selected 40 sites from LINEA's delivery, meeting the full activation target with 36 additional sites held as backup. 27% Above Target Delivery LINEA identified 27% more sites than the sponsor requested, providing strategic backup capacity in a highly competitive therapeutic area. Get the Full Story ## Download the case studyor see AcceleTrial live Get the one-page PDF summary or request a personalized demo using your protocol and therapeutic area. [Download One-Page Summary](https://www.lineasystem.com/case-study-ms-summary/?auto=1) [Request a Demo](https://www.lineasystem.com/contact/) [All Case Studies](https://www.lineasystem.com/resources/#case-studies) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/case-study-ms/* ======================================================================== # MS Case Study Summary **Source:** [https://www.lineasystem.com/case-study-ms-summary/](https://www.lineasystem.com/case-study-ms-summary/) **Published:** April 16, 2026 --- Save as PDF Case Study | Multiple Sclerosis 60 sites needed. *76 delivered.* How AcceleTrial helped a top pharma sponsor exceed site targets for a competitive Multiple Sclerosis trial. 50% of sites completed CDAs and Feasibility Questionnaires in under 7 days. 76 Sites Identified 50% CDAs + FQs Under 7 Days 40 Sites Selected 60 Sites Requested The Challenge ### Site identification at scale Identifying 60 sites (40 active, 20 backup) in a highly competitive Multiple Sclerosis therapeutic area. ### Compressed document timelines Executing CDAs and Feasibility Questionnaires with many clinical sites under an accelerated schedule. ### Efficient site activation Activating sites quickly and efficiently to meet or exceed the sponsor's targeted study timelines. The Solution Using AcceleTrial, LINEA identified 76 pre-qualified MS sites with specific expertise and patient access. 50% of sites completed both CDA and FQ in under 7 days. Rapid FQ turnaround enabled faster overall site selection. Site Criteria MS Clinical ExperienceTrial HistoryPatient AccessSpecific Expertise Outcomes ### 76 Sites Identified Delivered against a target of 60, providing full activation cohort plus strong backup. ### 50% CDAs and FQs Under 7 Days Half of all sites cleared both documents within 7 days, compressing the site selection cycle. ### 40 Sites Selected Sponsor activated full target from LINEA's delivery, with 36 additional sites in reserve. LINEA System · AcceleTrial® kcolatrella@lineasystem.com lineasystem.com --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/case-study-ms-summary/* ======================================================================== # MS Vaccine Case Study **Source:** [https://www.lineasystem.com/case-study-ms-vaccine/](https://www.lineasystem.com/case-study-ms-vaccine/) **Published:** April 16, 2026 --- The Challenge ## A niche patient profile.A tight timeline. A new modality. Finding sites with the right combination of MS expertise and access to vaccine-naive patients for an mRNA trial required a precision approach that traditional site identification methods could not deliver quickly enough. 01 Locating sites with vaccine-naive MS patients The sponsor needed 10 clinical sites with access to vaccine-naive MS patients, a specialized sub-population requiring both MS clinical expertise and specific patient history criteria. 02 Compressed timelines for CDAs and Feasibility Questionnaires The team needed to communicate with a large volume of clinical sites and execute CDAs and Feasibility Questionnaires on an accelerated schedule, with no room for slow document cycles. 03 Efficient, rapid site activation Sites needed to be activated quickly and efficiently to exceed the sponsor's targeted timelines. For a novel mRNA study with a niche patient group, every lost week created compounding risk. The Solution ## 12 MS sites.50% faster document collection. Using AcceleTrial, LINEA System identified 12 sites with specific MS clinical expertise and the right patient access profile. The platform collected all necessary study documents at a 50% faster rate than standard timelines. LINEA provided key contributing clinical sites and investigators evaluated against a rigorous set of qualification criteria, ensuring each site was genuinely prepared to enroll the right patients for this novel mRNA trial. Site Qualification Criteria MS Clinical ExperienceTrial HistoryCOVID-ReadinessDebarment CheckPatient Access AcceleTrial® | MS Vaccine Study Performance 12 **Sites Identified**Specialist MS sites with vaccine-naive patient access, exceeding target of 10 50% **Faster Document Collection**CDAs and FQs collected at half the typical timeline 7 **LINEA Sites Selected**7 LINEA-sourced sites selected for the mRNA vaccine response trial 5+ **Qualification Criteria**Each site evaluated against trial history, COVID-readiness, debarment, and clinical experience Outcomes ## Specialist sites found.Timeline beaten. 12 Sites Identified 12 specialist MS sites with vaccine-naive patient access delivered against a target of 10, exceeding the request on first delivery. 50% Faster Document Collection All necessary study documents collected at 50% the standard timeline through AcceleTrial's automated workflow. 7 LINEA Sites Selected 7 LINEA-sourced sites selected for inclusion in the mRNA vaccine response study from the 12 identified. 20% Above Target Delivery LINEA identified 20% more sites than the sponsor's requirement, providing a qualified reserve in a narrow patient population. Get the Full Story ## Download the case studyor see AcceleTrial live Get the one-page PDF summary or request a personalized demo using your protocol and therapeutic area. [Download One-Page Summary](https://www.lineasystem.com/case-study-ms-vaccine-summary/?auto=1) [Request a Demo](https://www.lineasystem.com/contact/) [All Case Studies](https://www.lineasystem.com/resources/#case-studies) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/case-study-ms-vaccine/* ======================================================================== # MS Vaccine Case Study Summary **Source:** [https://www.lineasystem.com/case-study-ms-vaccine-summary/](https://www.lineasystem.com/case-study-ms-vaccine-summary/) **Published:** April 16, 2026 --- Save as PDF Case Study | MS / mRNA Vaccine Response Vaccine-naive MS patients. *12 sites delivered.* How AcceleTrial identified specialist MS sites with vaccine-naive patient populations for an mRNA vaccine response trial, with documents collected at 50% the standard rate. 12 Sites Identified 50% Faster Document Collection 7 LINEA Sites Selected 10 Sites Requested The Challenge ### Vaccine-naive MS patient access Finding 10 sites with access to vaccine-naive MS patients, a specialized sub-population with strict eligibility criteria. ### Compressed document timelines Executing CDAs and Feasibility Questionnaires with clinical sites under an accelerated schedule. ### Efficient site activation Activating sites efficiently to exceed targeted timelines for a novel mRNA study modality. The Solution Using AcceleTrial, LINEA identified 12 MS sites with specific expertise and vaccine-naive patient access. Documents were collected at 50% the standard rate. Sites were evaluated against trial history, COVID-readiness, debarment status, and clinical experience. Site Criteria MS Clinical ExperienceTrial HistoryCOVID-ReadinessDebarment CheckPatient Access Outcomes ### 12 Sites Identified Exceeded sponsor target of 10, providing both the selected pool and reserve sites. ### 50% Faster Document Collection CDAs and FQs collected at half the standard timeline through AcceleTrial automation. ### 7 LINEA Sites Selected 7 LINEA-sourced sites chosen for the mRNA vaccine response study. LINEA System · AcceleTrial® kcolatrella@lineasystem.com lineasystem.com --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/case-study-ms-vaccine-summary/* ======================================================================== # PBC Case Study **Source:** [https://www.lineasystem.com/case-study-pbc/](https://www.lineasystem.com/case-study-pbc/) **Published:** April 16, 2026 --- The Challenge ## Rare disease. Rescue context.Legal and clinical timelines running in parallel. Adding sites to an ongoing rare disease study while navigating compressed timelines and legal CDA cycles required a platform capable of managing multiple parallel workflows without losing speed. 01 Identifying 20 additional sites in a rare disease indication The sponsor needed 20 additional clinical sites for a Primary Biliary Cholangitis study. PBC is a rare disease with a limited pool of sites that have genuine hepatology expertise and the right patient population. 02 Compressed timelines with legal CDA overhead Legal CDA negotiation had to run in parallel with clinical feasibility outreach and document collection, all within a compressed rescue timeline. 03 Efficient activation to meet rescue timelines As a rescue engagement, urgency was elevated. Sites needed to be activated efficiently and quickly. Any delay in identification or document execution had immediate impact on the study's enrollment trajectory. The Solution ## 21 hepatology sites.2 to 3 days, plus internal CDA support. Using AcceleTrial, LINEA System identified 21 sites with specific hepatology trial expertise and the right PBC patient access profile. Turnaround for feasibility and CDAs was 2 to 3 days, exceeding the sponsor's expectations. LINEA incorporated its internal CDA negotiation service to handle the legal cycle in parallel with clinical qualification. All study documents were collected at 50% the standard timeline. Sites were evaluated across trial history, COVID-readiness, debarment status, and clinical experience. Site Qualification and Service Criteria Hepatology Trial ExperienceTrial HistoryCOVID-ReadinessDebarment CheckPatient AccessInternal CDA Negotiation AcceleTrial® | PBC Rescue Study Performance 21 **Sites Identified**Hepatology specialist sites, exceeding target of 20 2-3 **Days to Feasibility and CDAs**Including internal CDA negotiation, turnaround exceeded expectations 18 **Sites Approved for PSV**18 of 21 LINEA sites received Protocol Site Visit approval 50% **Faster Document Collection**All study documents at half the standard timeline Outcomes ## Rescue delivered.Rare disease expertise at speed. 21 Sites Identified 21 hepatology specialist sites identified against a target of 20, each qualified against protocol criteria for this rare PBC indication. 18 Sites Approved for PSV 18 of LINEA's 21 sites received Protocol Site Visit approval, an 86% PSV approval rate from a rescue-context site pool. 2-3 Days Feasibility Turnaround Feasibility and CDAs completed in 2 to 3 days, including LINEA's internal CDA negotiation, exceeding sponsor expectations. 50% Faster Document Collection All necessary study documents collected at 50% the standard timeline, eliminating manual coordination delays. Get the Full Story ## Download the case studyor see AcceleTrial live Get the one-page PDF summary or request a personalized demo using your protocol and therapeutic area. [Download One-Page Summary](https://www.lineasystem.com/case-study-pbc-summary/?auto=1) [Request a Demo](https://www.lineasystem.com/contact/) [All Case Studies](https://www.lineasystem.com/resources/#case-studies) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/case-study-pbc/* ======================================================================== # PBC Case Study Summary **Source:** [https://www.lineasystem.com/case-study-pbc-summary/](https://www.lineasystem.com/case-study-pbc-summary/) **Published:** April 16, 2026 --- Save as PDF Case Study | Primary Biliary Cholangitis (Rare Disease) 21 hepatology sites. *Rescue timeline delivered.* How AcceleTrial helped a global biopharma company add specialist PBC sites to an ongoing study in a compressed rescue timeline, including internal CDA negotiation support. 21 Sites Identified 18 Sites Approved for PSV 2-3 Days Feasibility Turnaround 50% Faster Documents The Challenge ### 20 additional sites in a rare disease TA PBC limits the eligible site pool to those with genuine hepatology expertise and the right patient population. ### Legal CDA overhead on compressed timeline CDA negotiation running in parallel with feasibility outreach and document collection under rescue urgency. ### Rescue activation speed Every delay in identification or document execution had immediate impact on the ongoing study's enrollment trajectory. The Solution Using AcceleTrial, LINEA identified 21 sites with hepatology expertise and PBC patient access. LINEA incorporated its internal CDA negotiation service to clear the legal cycle in parallel. Feasibility and CDAs were completed in 2 to 3 days. Documents were collected at 50% the standard rate. Site Criteria Hepatology Trial ExperienceTrial HistoryCOVID-ReadinessDebarment CheckPatient AccessInternal CDA Negotiation Outcomes ### 21 Sites Identified Exceeded the rescue target of 20 additional sites in a rare disease indication. ### 18 Sites Approved for PSV 18 of 21 LINEA sites received Protocol Site Visit approval, an 86% PSV rate. ### 2-3 Day Turnaround Feasibility and CDAs including internal negotiation completed in 2 to 3 days. LINEA System · AcceleTrial® kcolatrella@lineasystem.com lineasystem.com --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/case-study-pbc-summary/* ======================================================================== # Privacy Policy old **Source:** [https://www.lineasystem.com/privacy-policy-old/](https://www.lineasystem.com/privacy-policy-old/) **Published:** November 2, 2021 --- Last updated: November 1, 2022 1. **Introduction** This Privacy Policy describes the types of information gathered by LINEA System, LLC (“LINEA System,” “us” or “we”) in the process of providing this website, [https://www.lineasystem.com/](https://www.lineasystem.com/), (the “Site”), and the associated services, software (including, but not limited to AcceleTrialTM), data, information, tools, functionality, updates and similar materials (collectively, with the Site, the “Service”), as well as how we use it, with whom the information may be shared, what choices are available to you regarding collection, use and distribution of information and our efforts to protect the information you provide to us through the Service. 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Please refer to the “Last updated” date above to see when this Privacy Policy was last updated. - **Territoriality.**Regardless of where our servers are located, your personal data may be processed by us in the United States, where data protection and privacy regulations may or may not be to the same level of protection as in other parts of the world. In all instances in this Privacy Policy, “our servers” means servers that we own or on which the Service is hosted, or which are otherwise utilized by the Service.  BY VISITING THE SITE AND USING THE SERVICE, YOU UNEQUIVOCALLY AND UNAMBIGUOUSLY CONSENT TO THE COLLECTION AND PROCESSING IN THE UNITED STATES OF ANY INFORMATION COLLECTED OR OBTAINED BY US THROUGH VOLUNTARY SUBMISSIONS, AND, TO THE EXTENT POSSIBLE, THAT U.S. LAW GOVERNS ANY SUCH COLLECTION AND PROCESSING. - **This Privacy Policy may be subject to the provisions of the European Union’s General Data Protection Regulation (“EU GDPR”), the ****United Kingdom’s General Data Protection Regulation (“UK GDPR”, and together with the EU GDPR, the “GDPR”),**** and other applicable privacy laws. LINEA System agrees that under the GDPR, it is both a data “Controller” and a “Processor”, and you, if you are an individual and reside in the European Economic Area, United Kingdom, or Switzerland (collectively, the “EEA”), are a “Data Subject” with certain protected privacy rights concerning your “Personal Data.” We will take reasonable steps to maintain compliance with GDPR requirements. Your Personal Data may identify you as a person, and thus may be referred to as Personally Identifiable Information (“PII”).** **Who Collects Your Information On Our Site?** We do. Under the GDPR, LINEA System is what is known as a “Controller” and a “Processor” of the Personal Data that is processed by LINEA System and collected from you, and third party sources, including but not limited to publicly and commercially available databases.  Additionally, we may collect information from you on the Service, and we are responsible for protection of your information. - **What Information Do We Collect?**Personally Identifiable Information. We may request specific PII from you when you register for the Service, when you create or update your account, when you use the Service, from third parties, when you communicate or interact with us, or otherwise when you submit such information. You may choose not to provide your PII, but then you might not be able to take advantage of some of the features of our Site and Service. The types of PII we may collect and save include:Contact and account registration information such as username, name, address, email address, physical/mailing address, and telephone number; - Information you provide such as feedback, comments or other messages; - Technical information collected in our logs, such as standard web log entries that contain your IP address, keystrokes and clicks while using the Site, page URLs, the pages and features accessed most frequently, time spent on a page, how pages and features are used, previous page and referring page URLs, search terms entered, and similar analytics about use of the Site or Service; and - Clinical Trial Related, as defined herein. - Clinical Trial Related. We may collect information that you upload or otherwise submit, including but not limited to your CV/qualifications, a feasibility questionnaire, and regulatory documents, to the Service to use the clinical trial related functions the Service offers (“Clinical Trial Related Content”). We collect Clinical Trial Related Content only if, and to the extent that, you upload or otherwise submit it to the Service. - Anonymous Information. We may also collect anonymous, non-identifying and aggregate information such as the type of browser you are using, device type, the operating system you are using, and the domain name of your Internet service provider. We may create anonymous or de-identified information from PII. 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If you currently reside in the EEA, the GDPR applies to your PII and you are a Data Subject.  The GDPR requires that we, in our capacity as a Controller, have a legal basis to process your PII.  We process your PII under one or more of the following legal bases: - Processing is necessary for our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests; - For the performance of a contract; - To comply with a legal obligation; and/or - If we have your consent to do so, such consent capable of being revoked at any time. 1. Under the GDPR, as a Data Subject you have certain rights. They are: - The right to be informed. This is your right to be informed about what we are processing, why, and who else the data may be passed to. - The right of access. This is your right to see what data about you is held by us. - The right to rectification. 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Canonical HTML: https://www.lineasystem.com/privacy-policy-old/* ======================================================================== # Resources **Source:** [https://www.lineasystem.com/resources/](https://www.lineasystem.com/resources/) **Published:** April 6, 2026 --- Featured Resource Playbook The AI Site Selection Playbook for *Clinical Sponsors* A practical, step-by-step framework for integrating AI and data tools into your site selection workflow. Covers protocol configuration, site scoring, feasibility automation, and startup compression strategies used by leading sponsors. [Download the Playbook](https://www.lineasystem.com/get-playbook/) Key Finding Up to 50% Faster trial start-up timeline when beginning with the right sites and protocol-aware activation workflow AcceleTrial Platform Outcomes Case Studies ## Results sponsors achieved with LINEA Case Study · Multiple Sclerosis 76 Sites Delivered Against a Target of 60 for a Relapsing MS Trial A sponsor needed 60 qualified sites. LINEA delivered 76, with 50% of CDAs and feasibility questionnaires completed within seven days of outreach. [Read the Case Study](https://www.lineasystem.com/case-study-ms/) Case Study · Multiple Sclerosis 12 Sites Identified for a Vaccine Response Study in Vaccine-Naive MS Patients With a target of 10 sites and a narrow vaccine-naive eligibility requirement, LINEA identified 12 qualified sites and cut document turnaround time in half. [Read the Case Study](https://www.lineasystem.com/case-study-ms-vaccine/) Case Study · Cardiovascular 65 Sites Delivered for an Acute Coronary Syndrome Trial, 46 Selected A cardiovascular sponsor needed sites with ACS trial experience across a compressed timeline. LINEA delivered 65 qualified sites with a 2-to-3-day document turnaround. [Read the Case Study](https://www.lineasystem.com/case-study-acs/) Case Study · Hepatology 21 Sites Identified for a Primary Biliary Cholangitis Trial, 18 Approved for PSV For a rare hepatology indication with strict eligibility criteria, LINEA identified 21 sites against a target of 20. Eighteen were approved for Protocol Site Visits. [Read the Case Study](https://www.lineasystem.com/case-study-pbc/) Guides & Playbooks ## Practical resources for clinical operations teams Guide Common Questions Guide for AcceleTrial Answers to the most common operational questions sponsors and site teams have about AcceleTrial workflow, document handling, and activation steps. [Read the Guide](https://www.lineasystem.com/guide-acceletrial-faq/) Playbook · AI in Clinical Trials AI Integration Playbook for Clinical Operations Leaders A 5-step framework for evaluating, piloting, and scaling AI across the clinical trial workflow. Covers governance, use case selection, pilot design, and enterprise-wide integration. [Read the Playbook](https://www.lineasystem.com/get-playbook/) Primer · Site Partnerships Site Primer: Building Stronger Site Relationships by Leveraging AI A partnership-first, AI-enabled framework for identifying, activating, and supporting clinical trial sites across the study lifecycle, from feasibility through enrollment support. [Read the Primer](https://www.lineasystem.com/site-primer/) Blueprint · Intelligent Operations AI Blueprint for Intelligent Operations A unified, end-to-end model, Audit, Activate, Accelerate, Amplify, and Augment, that sponsors, CROs, and research organizations use to modernize their operations with AI. [Read the Blueprint](https://www.lineasystem.com/ai-blueprint/) Briefing · FDA Real-Time Clinical Trials RTCT Site-Readiness Briefing What the FDA move to real-time clinical trials changes about site selection: the pilot timeline, the workflow before and after, the EHR question, six feasibility questions to add now, and what the agency has not answered yet. [Read the Briefing](https://www.lineasystem.com/rtct-briefing/) Guide Measuring Site Selection ROI: A Framework for Clinical Operations Leaders A practical framework for quantifying the cost of poor site selection and calculating the ROI of data-driven approaches, built for budget conversations and leadership presentations. [Read the Guide](https://www.lineasystem.com/guide-site-selection-roi/) Browse by Topic ## Find what you need right now Site Scoring Feasibility Investigator Intelligence Contract & Startup Geographic Strategy Regulatory Data Enrollment Forecasting AI in Clinical Trials Clear filter --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/resources/* ======================================================================== # RSI **Source:** [https://www.lineasystem.com/rsi/](https://www.lineasystem.com/rsi/) **Published:** April 6, 2026 --- What the RSI Is ## Not a list. A deterministically scored investigator intelligence platform. Most site lists are static, unverified, and protocol-agnostic. The RSI scores every investigator record against your specific protocol parameters: therapeutic area, phase, indication, and patient population. The result is a ranked, ready-to-use site list in minutes, not weeks. **Monthly refresh with real-time updates on request**, backed by validation-based source persistence and quality controls **Protocol-aware scoring** across trial experience, clinical volume, recency, and five further components, reweighted for each therapeutic area and phase **20 supported UI languages** for global sponsor and operations teams using the RSI runtime RSI Overview 248K+ Investigator Records 186 Countries 43K+ US Institutions 181 Specialties 12 UI Languages 2008 Founded RSI Data Preview ## What a site record looks like Research Site Index: Query Results Illustrative example. Sites and investigators are anonymised and scores are representative, not real records. Site / Principal InvestigatorIndicationLast TrialScoreStatus Academic medical center, Midwest US Principal investigator A Oncology 2025 Q4 7.3 Active NCI-designated cancer center, South US Principal investigator B Oncology 2026 Q1 7.1 Active Comprehensive cancer center, Northeast US Principal investigator C Oncology 2025 Q3 6.8 Active Teaching hospital, Northeast US Principal investigator D Oncology 2025 Q2 6.4 Active University health system, Mid-Atlantic US Principal investigator E Oncology 2024 Q4 5.9 Watch Protocol-Aware Scoring Model ## Deterministically scored across eight components. One composite RSI score. Eight weighted components produce one composite score on a 0 to 10 scale. The weights shift by therapeutic area and trial phase, so the same site is ranked differently for an oncology Phase III than for a dermatology Phase I. The same inputs always produce the same result, and that result powers the ranked site list in AcceleTrial. 01 Trial Experience Depth of registered trial history, and how the investigator ranks against the full index. The one component available for every record worldwide. 02 Clinical Volume The size of the real patient panel behind the site, from licensed claims and prescribing data. Coverage is strongest in the United States. 03 Recency Time since the most recent trial on record. Recent work counts for more, and how fast that falls away is tuned by specialty, so a three-year gap reads differently in oncology than in dermatology. 04 Industry Engagement Evidence the investigator already works with industry sponsors. Coverage is strongest in the United States. 05 Patient Access The population a study can realistically recruit from around the site's location. Coverage is strongest in the United States. 06 FDA Track Record Regulatory inspection history. A site inspected and cleared scores above one never inspected at all, and an unresolved finding counts heavily against. 07 Recognition Publication record and citation standing for the named investigator. Available globally, not only in the United States. 08 Startup Speed How quickly the site has historically moved from selection to activation, including its ethics review and contracting model. Not every signal exists for every investigator. Several components draw on data whose coverage is strongest in the United States, so they are thinner across much of the international index. Rather than scoring a missing signal as zero, which would penalise a site simply for being outside the United States, the engine renormalises across the components it does have and pulls the result toward the index-wide average in proportion to what is missing. A site with thin coverage lands near the middle of the scale, not at the bottom. So the score reflects both how strong a site's record is and how much we know about it. RSI Score Breakdown: academic medical center, Midwest US / Oncology Phase III 7.3 Composite RSI Score Illustrative example on the 0 to 10 scale. Trial Experience 6.0 Clinical Volume 5.5 Recency 4.8 Industry Engagement 4.2 Patient Access 5.1 FDA Track Record 3.6 Recognition 4.6 Startup Speed 3.0 What Each Site Record Contains ## Every data point that matters for site selection Investigator Profiles Full PI and sub-investigator credentials, board certifications, publication history, active trial load, and years of experience by indication. Enrollment Performance Historical enrollment rates against projected targets, broken down by phase, indication, and sponsor type across all prior trials. Regulatory History Regulatory inspection outcomes, audit findings, and protocol deviation history. Every compliance event on record. Sponsor Relationship Data Every prior engagement this site has had with sponsors and CROs: contracts executed, performance ratings, and communication history. Patient Population Data Demographic catchment analysis, disease prevalence in the site's geography, and patient pool estimates for specific indications. Startup Velocity Metrics IRB turnaround times, contract-to-SIV timelines, and first-patient-in dates from prior trials, giving a predictive view of activation speed. Therapeutic Coverage ## Virtually all therapeutic areas, 186 countries The current RSI runtime exposes 181 normalized specialty options covering virtually all therapeutic areas, with 43,000+ distinct US institution labels and global coverage across 186 countries. OncologyCardiologyNeurologyImmunologyInfectious DiseaseEndocrinologyRheumatologyPsychiatryPulmonologyGastroenterologyRare DiseaseDermatologyOphthalmologyHematologyNephrologyPain ManagementPediatricsWomen's Health How the RSI Stays Current ## Monthly refresh, real-time on request Site data decays fast. RSI data is refreshed monthly and can be updated in real-time when requested. Validation-backed source persistence and quality controls keep the intelligence layer current. Access the RSI ## The verified data yoursite decisions deserve RSI access is available as a standalone product or as the data foundation behind an AcceleTrial engagement. Contact us to discuss what fits your program. [Request RSI Access](https://www.lineasystem.com/contact/)[See AcceleTrial](https://www.lineasystem.com/acceletrial/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/rsi/* ======================================================================== # RTCT Site-Readiness Briefing **Source:** [https://www.lineasystem.com/rtct-briefing/](https://www.lineasystem.com/rtct-briefing/) **Published:** July 24, 2026 --- 01 The regulatory shift Two changes, arriving together Real-time signal reporting and the single pivotal trial are separate decisions. Their effect on site selection compounds. 01 Signals reach the FDA through a platform, not a pipe Two proof-of-concept trials are live: AstraZeneca's **TRAVERSE** (Phase II, treatment-naive mantle cell lymphoma, sites including MD Anderson and the University of Pennsylvania) and Amgen's **STREAM-SCLC** (Phase Ib, limited-stage small cell lung carcinoma). Both report pre-agreed safety and efficacy signals as data emerges. The data does not move from the site straight to the agency. It passes through an intermediate platform, Paradigm Health in the current pilots, which validates the signal first. 02 One pivotal trial, one shot In February 2026 the FDA made a **single pivotal trial** with confirmatory evidence the default for approval, ending the two-trial standard set in the 1960s. A sponsor now gets one chance to get the study right. A misjudged site no longer costs a few months of enrollment. It can cost the approval, and under RTCT the agency sees the damage while it is happening. 02 Where we are in the process The pilot timeline is moving fast Sponsors and sites that want a seat in the broader pilot have a narrow window to prepare. Apr 28 RTCT announced Two proof-of-concept trials unveiled, RFI released May 27 Comments extended FDA pushes the RFI deadline to June 29 Jun 29 Comments closed Final window for sponsor and site input on pilot design Jul 2026 Criteria published FDA expected to release final pilot selection criteria Aug 2026 Selections complete Broader pilot participants, sponsors and platforms, finalized **On the leadership question.** Two of the initiative's most visible champions, Commissioner Makary and Jeremy Walsh, have both left the agency, and no successor has taken up the file publicly. The pilot timeline has not moved. Once an agency sees how much faster it can review a submission, that capability tends not to get handed back, which makes early and well-documented site readiness worth more, not less. 03 The workflow, before and after Every step survives. The clock underneath them does not. RTCT does not remove steps, it compresses them and runs several of them continuously. The steps in bold change character, not just speed. The standard Traditional model The shift RTCT model Site identified Site identified Feasibility **Feasibility, in depth.** *Data framework and EHR capability assessed, not just clinical fit* Selected Selected Activated **Activated** *with the data framework and IT routing already standing up* Patient enrolled Patient enrolled Data collected on the CRF **Data collected on the CRF, or signals streamed.** *The clinician documents in the EHR at the visit and pre-agreed safety and efficacy fields flow into an intermediate platform* Source data verification Source data verification, **in real time** Entered in the EDC Entered in the EDC, modified, **or an intermediate database** Monitor reviews, queries Monitor reviews and queries, **real time and remote** Database lock **Ongoing.** *What it takes to change data already streamed to the agency is still an open question* Statistical analysis Statistical analysis **as data becomes available** Clinical study report Clinical study report becomes a **supporting document** NDA submitted to the FDA NDA becomes a **supporting document** 04 Operational reality Real-time data demands real-time sites RTCT does not change informed consent or core governance requirements. It changes the speed and discipline a site has to operate with from the day enrollment opens. 01 Capture at the point of care Signals recorded and transmitted as they occur, not batched for a monthly export. 02 Interoperable systems EHR, EDC, and safety tools that talk to each other without manual reconciliation. 03 Faster query turnaround A delayed response now has a visible cost to the sponsor and the agency in near real time. 04 Continuous safety vigilance Adverse event review and escalation can no longer wait for a scheduled monitoring visit. 05 Staff bandwidth for oversight Coordinators need dedicated time for continuous review, not just visit-day documentation. 06 Data integrity under speed Faster reporting cannot come at the cost of accuracy, source verification, or patient privacy. 05 The technology question has changed The question is no longer whether a site has an EHR Certified EHR adoption is close to universal, so the presence of a system tells a sponsor almost nothing. Which system, whether it exposes an API, and how much manual work sits between the visit and the data are what separate a site that can stream from a site that cannot. Certified EHR use among office-based physicians, by practice ownership 87% 93% 98% 98% 99% 99% Physician-ledOther health corp.HMOOther hospitalFQHCAcademic Most common EHR Epic 27.7% of office-based physicians report Epic as their primary system. Meditech**11.1%** eClinicalWorks**7.5%** athenahealth**7.3%** Cerner / Oracle Health**5.5%** Epic's lead widens in hospitals: 43.7% of acute-care hospitals and 56.9% of inpatient beds. Solo and physician-owned practices lag furthest behind, and academic centers lead. But size cuts both ways. A large institution where the investigator sees the patient and the clinic note reaches the EHR two or three days later is not real-time ready either, whatever the system on the label says. 06 Selecting the right sites is now risk management Feasibility stops being a checklist and becomes an assessment The fundamentals did not move. What sits beside them did. A site now has to clear both columns, and it has to clear them before the first patient is enrolled rather than during the study. Still required The fundamentals Expertise Verified depth in the indication, not a claim of it. Experience A real track record of running trials to enrollment and clean data. Documented patient access A **current, verifiable** referral pipeline, and evidence the site converts those patients into participants. Operational discipline Process workflows mapped clearly enough to show how data and decisions move at the point of care. Dedicated staff capacity Coordinators and investigators with bandwidth to monitor continuously, not when other work allows. Reputation is not evidence A site's brand, or a long relationship, does not guarantee it can meet RTCT reporting speed today. Now also required RTCT readiness Interoperable EHR A modern system supporting **FHIR and HL7** exchange. Paper or closed systems are a go / no-go risk. Real-time capture at the point of care Data recorded during the visit, not dictated and entered weeks later. Connected EDC and safety reporting A defined source-verification and query model for streamed data, and a routing path to the intermediate platform. Hours, not weeks Query turnaround and adverse-event escalation the site can sustain continuously, not in bursts. Capacity and budget Dedicated staff for ongoing review, and contract language that **pays the site** for the added technology work. Willingness to be trained Real-time workflow is new to nearly every site. The ones that will succeed say yes to training up front. 07 Put these in your next feasibility Six questions that belong in every questionnaire now None of these are clinical questions, and the investigator often cannot answer them alone. Expect the site to pull in IT or its EHR administrator, and build that time into the feasibility window. 01 Are assessments done at the point of care ready for sharing, or do they require internal review first? The single best predictor of whether a site can stream at all. 02 Which certified EHR does your site, practice, or institution currently use? The sponsor needs the system's capabilities to judge compatibility with the study's EDC. 03 Can your site or research team commit to responding to queries within 48 hours? Ask for the commitment in writing and put the number in the contract. 04 Can your site report adverse events directly to the FDA as they occur, if pre-agreed? Surfaces both the technical path and the site's comfort with using it. 05 What is the study coordinator's role in real-time assessment and data documentation? Names the person who owns the cadence, before activation rather than after. 06 Is your site willing to be trained to manage RTCT? Almost no site has done this before. Willingness matters more than experience right now. **Why question 03 is the one to hold the line on.** Query volume is the pressure point. A single trial can accumulate tens of thousands of queries over its duration, and under RTCT that backlog is visible to the agency while the study is still running. Site performance stops being measured on enrollment alone and starts being measured on responsiveness, which means the median query cycle time already sitting in your EDC becomes a site selection input rather than a closeout statistic. 08 Raised in session, still unanswered by the agency What nobody can tell you yet These came from the sponsors, CROs, and site networks on the Mastermind call. The FDA has not published guidance on any of them. 01 Does every site have to participate? Partial participation would skew an analysis that runs continuously. **Our reading, shared by several public comments, is that it has to be every site in a study.** The FDA has not said so. 02 What counts as clean enough to stream? Whether a CRA and the sponsor verify and freeze a field before the interface pushes it to the agency is undefined. Nobody wants conclusions drawn from unreviewed data. 03 How does this fold into risk-based monitoring? RBM already targets specific fields for near-real-time review. Whether RTCT absorbs it, runs alongside it, or replaces it is not settled. 04 How do you correct data already streamed? There is no published mechanism for retracting or amending a signal the agency has already received. This is the question sponsors raise first. 05 Who trains the sites, and when? Whether the site initiation visit still carries this, and who funds the added effort, is open. The training burden is real and it lands on the site. 06 What does the consent say? Participants may need to be told that data about their response reaches the agency before the study ends. Expect consent language to catch up. One more point from the room: **not every protocol suits RTCT.** In rare disease, where a site can go months between eligible patients, continuous signal reporting may distort more than it reveals. Expect sponsors to designate which protocols take the real-time route. 09 Contingency planning When a site underperforms mid-study With one pivotal trial and a continuous readout, the response to a stalled site has to be designed before activation, not improvised at the six-month mark. 01 Set the trigger before activation Define the screening or enrollment threshold, and the date it gets checked, in the contract. Not in the first steering committee after it is already late. 02 Make closing out normal A site or network that can say "we thought we had these patients and we do not" early is worth more than one that waits. Transparency has to be safe, or it does not happen. 03 Identify the backup first If a region has to contribute a set number of patients, the replacement site should be known before the original one stalls, not sourced afterward. 04 Widen the funnel before you close Geofenced referral outreach in a 10 to 50 mile radius around an otherwise strong site can restore supply without losing the investigator and the activation spend. The takeaway ## The fundamentals have not changed.The cost of getting them wrong has. You still need investigators with real depth in the indication, a verifiable path to the right patients, and a research team that can execute. What is new is that a weak site is no longer a delay you absorb quietly. It is a risk to the program, visible to the agency while the study is still running, in a world where one pivotal trial carries the approval. 01 Can this site reach the right patients **today**, not eventually? 02 Can it report data at the **speed** the protocol demands? 03 What is the plan when it **underperforms** mid-study? **Want the answers for your own site list?** We validate expertise, experience, and patient access with objective site intelligence before enrollment opens. Get the Full Briefing ## Download the PDFor see AcceleTrial live Take the four-page briefing to your team, or request a walkthrough of how we score sites on readiness rather than reputation. [Download the RTCT Briefing PDF](https://www.lineasystem.com/wp-content/uploads/playbooks/rtct-briefing.pdf) [Request a Demo](https://www.lineasystem.com/contact/) [All Resources](https://www.lineasystem.com/resources/) **Sources:** FDA, "FDA Announces Major Steps to Implement Real-Time Clinical Trials" (Apr 28, 2026); FDA RFI comment-period extension, Federal Register (May 27, 2026); Makary and Prasad, New England Journal of Medicine, single-pivotal-trial default (Feb 2026); Commissioner Makary resignation reported May 12, 2026 (NBC, Washington Post, CBS, Time); FDA Chief AI Officer estimate of a 20 to 40% timeline reduction; ONC / HealthIT.gov, 2024 National Electronic Health Records Survey (N=1,725); KLAS 2026 EHR Market Share Report. Open questions and site-level practice reflect the discussion at LINEA Mastermind Session 9, July 23, 2026. --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/rtct-briefing/* ======================================================================== # Site Primer **Source:** [https://www.lineasystem.com/site-primer/](https://www.lineasystem.com/site-primer/) **Published:** July 18, 2026 --- 01 Section 01 Strategic Site Identification Identify the right sites through measured evidence, not reputation or guesswork. 01 Patient Access Catchment population and historical enrollment data to verify real patient availability. 02 Operational Capabilities Assess site type, infrastructure, staffing, and past trial execution, not through audits but through collaborative dialogue and data-supported validation. 03 Knowledge Retention Leverage structured summaries of prior site engagement and knowledge already captured, stored, and reviewed to identify partnership opportunities. 02 Section 02 Feasibility That Respects Time and Adds Value Use AI tools to ensure feasibility questionnaires are frictionless, transparent, and fair to the site. 01 Frictionless Ask only what is essential to execute the trial protocol. 02 Transparent Use a centralized tool to share feasibility forms, timelines, and Q&A, with no email attachments or spreadsheets. 03 Time-Bound Set clear deadlines for completion (for example, 5 business days) and guarantee review, next step, and final decisions. 04 Ending the Knowledge Gap Most sponsors lack a central repository tracking what studies the sites have already completed for them. Without it, sites waste time repeating themselves. Use AI to aggregate historical data. 03 Section 03 Re-Designing the Pre-Study Visit (PSV) Schedule virtual PSVs when the site already has history with the sponsor. 01 Summarize and Validate Use AI to summarize previous engagements and validate new requirements for the trial protocol, within a fixed number of days post-feasibility approval. 02 Agendas and Data Capture Use AI-generated agendas and data capture to minimize manual notes and ensure completeness. Structured, focused questions that get to the core of the site's setup to support the trial protocol. 03 Enhance Site Experience Use AI to deliver shorter, structured virtual sessions with pre-submitted documents reviewed by AI before the meeting, with clear follow-up actions that build trust and collaboration, not just compliance. 04 Section 04 Clear, Prompt Communication for Site Selection Use AI to generate a customized commitment letter and keep site startup simple. 01 Clear Outline The letter outlines team roles, contact information, timelines, and next steps. 02 Collaboration Provide immediate access to start-up templates and platforms for centralized collaboration. 03 Limit Systems Overload When more than three platforms are required, trial operations become unruly: endless logins, training, and updates that pull attention away from patient care. Use AI to centralize, integrate, consolidate, or enable APIs to minimize the platforms sites must use for a single trial. 05 Section 05 AI-Supported Activation and Planning Compress activation timelines while protecting patient safety and trial integrity. 01 Contracts and Budgeting Use AI protocol-driven budgets matched to FMV benchmarks to reduce negotiation time. 02 Drug Supply Use AI to predict usage patterns and logistics to avoid supply gaps that could compromise patient safety or trial integrity. 03 Regulatory and Ethics Approval AI drafts regulatory documents and executive summaries to streamline submissions. 04 Investigator Training Precise, accurate training to execute the protocol, with AI converted into a training manual. 05 System and Tools Training AI learning summaries to facilitate operational efficiency with tools. 06 Section 06 Supporting Site Needs with Enrollment and Patient Care Meet sites where they are, supporting them with technology, tools, and training that reduce complexity and enhance capacity. Critical needs include: 01 Patient Identification Through EHR/EMR Mining AI can scan health records to match eligibility criteria, flag qualified patients, and prioritize by location and readiness, turning patient recruitment from a needle-in-a-haystack search into a streamlined process. 02 Patient Outreach and Engagement With natural language processing (NLP) and conversational AI, sponsors can equip sites with pre-approved, patient-friendly trial explanations, chatbots that answer common patient questions, and multilingual materials that explain risks and benefits in plain language. This helps patients feel informed and reduces site staff burden in repetitive education. 03 Reducing Recruitment Burden on Sites AI automates tasks like patient list generation, reminders, and recruitment tracking, freeing coordinators to focus on relationships instead of admin. 04 Building Trust and Transparency AI can analyze community sentiment and patient feedback to help sponsors understand why certain patient populations hesitate to join, what messaging builds trust, and how cultural or socioeconomic factors impact enrollment. Sponsors can then provide sites with tailored communication strategies that resonate locally. 05 Consistent Patient Messaging Sponsors can equip sites with AI-powered chatbots and multilingual education tools that answer common patient questions, explain trial details in plain language, and provide consistent, pre-approved messaging. 07 Section 07 Practical Strategies for Supporting Sites Meet sites where they are with tools that reduce complexity and enhance capacity. 01 Patient-First Scheduling Tools Use AI to recommend visit windows based on patient availability, clinic capacity, and weather. This minimizes no-shows and ensures more predictable site operations. 02 Pre-Packed Patient Visit Kits Just as “go bags” reduce chaos at home, standardized visit kits reduce variability and delays. Include labeled forms, pre-filled patient logs, lab kits, and IP tracking sheets. 03 Digital Patient Tracking Boards Give sites an easy way to monitor where patients are in their protocol journey. Include reminders for key milestones and alerts if a visit is overdue or missed. 04 Emotional Load Awareness Sponsor and CRO leads should have regular syncs with sites focused solely on support: what is working, what is breaking, and how to help. Not just status updates. 05 Evening and Weekend Site Support Recognize when sites are operating under duress. Offer access to real-time tech support or protocol guidance outside typical 9 to 5 hours, when many patient issues arise. 06 Backup Systems for Patient Care Plan for site staff outages with rotating support contacts and shared digital SOPs. When coordinators call out, the system should still support patient needs with minimal disruption. 07 Smart Nudges and Predictive Flags Use AI to watch for early signs of site distress (missed queries, overdue reports, slow enrollment) and trigger early support before issues cascade. 08 Checklist-Centered Thinking Embed operational checklists into site platforms: pre-visit prep, patient follow-up tasks, lab processing steps, and safety follow-ups. A good checklist is a silent assistant for busy staff. 09 Centralized FAQ Libraries Create dynamic, AI-searchable libraries of protocol-specific guidance, past clarifications, and key contacts. Sites should never have to guess or wait days for a CRO to respond. 10 Time-Saving Templates Offer ready-to-use SOPs, delegation logs, patient visit schedules, and communication scripts that require minimal customization, so site staff can focus on care, not document formatting. Conclusion ## Partnering,not auditing. Strong site relationships start with respect and communication. Replace vendor-style audits with partnership-style collaboration. Let AI remove administrative friction so your team and the site can focus on the shared mission: delivering clinical research that matters, and caring for patients with excellence every step of the way. **Not sure where to start?** Ask us how we can help you implement these recommendations effectively. Get the Full Primer ## Download the PDFor see AcceleTrial live Take the full framework with you or request a personalized demo to see how AcceleTrial applies AI across site identification, activation, and support. [Download the Site Primer PDF](https://www.lineasystem.com/wp-content/uploads/playbooks/site-primer.pdf) [Request a Demo](https://www.lineasystem.com/contact/) [All Resources](https://www.lineasystem.com/resources/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/site-primer/* ======================================================================== # Thank You! **Source:** [https://www.lineasystem.com/briefing/thanks/](https://www.lineasystem.com/briefing/thanks/) **Published:** April 24, 2026 --- [Home](https://www.lineasystem.com/) Platform [AcceleTrial®](https://www.lineasystem.com/acceletrial/) [Research Site Index](https://www.lineasystem.com/rsi/) Company [About Us](https://www.lineasystem.com/about/) [Leadership Team](https://www.lineasystem.com/about/#leadership) [Board of Advisors](https://www.lineasystem.com/about/#advisors) Resources [Guides & Case Studies](https://www.lineasystem.com/resources/) [The Clinical Signal Newsletter](https://www.lineasystem.com/the-clinical-signal/) [English](https://www.lineasystem.com/briefing/thanks/) [Español](https://www.lineasystem.com/es/gracias/) [Request Demo](https://www.lineasystem.com/contact/) Subscription Confirmed # Welcome to The Clinical Signal You are officially on the list. The next weekly briefing arrives in your inbox on the next weekly send date, with the most important developments in AI, clinical trials, and drug development, curated from industry sources. “The greatest opportunity to improve clinical trials is through site start-up. That is what LINEA was built to address.” Kathleen Colatrella, Founder [Read the latest issue](https://www.lineasystem.com/briefing/) [Back to lineasystem.com](https://www.lineasystem.com/) The LINEA System team We use cookies and analytics tools to understand how visitors use our site and to improve your experience. [Learn more](https://www.lineasystem.com/privacy-policy/) Decline Accept --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/briefing/thanks/* ======================================================================== # Thank You! **Source:** [https://www.lineasystem.com/playbook-thanks/](https://www.lineasystem.com/playbook-thanks/) **Published:** April 24, 2026 --- [Home](https://www.lineasystem.com/) Platform [AcceleTrial®](https://www.lineasystem.com/acceletrial/) [Research Site Index](https://www.lineasystem.com/rsi/) Company [About Us](https://www.lineasystem.com/about/) [Leadership Team](https://www.lineasystem.com/about/#leadership) [Board of Advisors](https://www.lineasystem.com/about/#advisors) Resources [Guides & Case Studies](https://www.lineasystem.com/resources/) [The Clinical Signal Newsletter](https://www.lineasystem.com/the-clinical-signal/) [English](https://www.lineasystem.com/playbook-thanks/) [Español](https://www.lineasystem.com/es/gracias-manual/) [Request Demo](https://www.lineasystem.com/contact/) Confirmed # Your Playbook is ready to read Your copy of the **AI Site Selection Playbook** is linked below. Open it anytime. [Open the Playbook](https://www.lineasystem.com/wp-content/uploads/playbooks/ai-clinical-trials-playbook.pdf) **What happens next** - The Playbook is yours to keep. Return to it anytime using the link above. - If you opted into **The Clinical Signal**, your first weekly briefing on AI in clinical trials arrives next week. - Want to see the framework applied to your own trial? Request a demo of AcceleTrial and the Research Site Index. [Request a demo](https://www.lineasystem.com/contact/) The LINEA System team We use cookies and analytics tools to understand how visitors use our site and to improve your experience. [Learn more](https://www.lineasystem.com/privacy-policy/) Decline Accept --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/playbook-thanks/* ======================================================================== # The Clinical Signal **Source:** [https://www.lineasystem.com/the-clinical-signal/](https://www.lineasystem.com/the-clinical-signal/) **Published:** May 6, 2026 --- [Home](https://www.lineasystem.com/) Platform [AcceleTrial®](https://www.lineasystem.com/acceletrial/) [Research Site Index](https://www.lineasystem.com/rsi/) Company [About Us](https://www.lineasystem.com/about/) [Leadership Team](https://www.lineasystem.com/about/#leadership) [Board of Advisors](https://www.lineasystem.com/about/#advisors) Resources [Guides & Case Studies](https://www.lineasystem.com/resources/) [The Clinical Signal Newsletter](https://www.lineasystem.com/the-clinical-signal/) [English](https://www.lineasystem.com/the-clinical-signal/) [Español](https://www.lineasystem.com/es/boletin-the-clinical-signal/) [Request Demo](https://www.lineasystem.com/contact/) Free Weekly Newsletter # The Clinical Signal The most important developments in AI, clinical trials, and drug development, curated from industry sources every week. - AI applications reshaping site selection and feasibility - Regulatory updates affecting trial operations - Drug development milestones across key therapeutic areas - Concise analysis, no vendor pitches, no filler First Name Email Address Subscribe, Free Something went wrong. Please try again or email [kcolatrella@lineasystem.com](mailto:kcolatrella@lineasystem.com). No spam. Unsubscribe anytime. [Privacy Policy](https://www.lineasystem.com/privacy-policy/). [Read a sample issue first](https://www.lineasystem.com/briefing/) We use cookies and analytics tools to understand how visitors use our site and to improve your experience. [Learn more](https://www.lineasystem.com/privacy-policy/) Decline Accept --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/the-clinical-signal/* ======================================================================== # The Future of Decentralized Trials **Source:** [https://www.lineasystem.com/2021/01/08/the-future-of-decentralized-trials/](https://www.lineasystem.com/2021/01/08/the-future-of-decentralized-trials/) **Published:** January 8, 2021 --- By Sarah Hof Decentralized trials are here to stay, and major pharma companies have already bought into their effectiveness, as reported by [FierceBiotech](https://www.fiercebiotech.com/). While the operational component of decentralized or remote trials once posed a logistical hindrance, the pandemic has forced rapid advancements in the means to ensure an increasingly smooth experience for both patients and investigators.  A lesser-known boon to remote trials’ wider adoption was how during the spring of 2020 when the pandemic was nearing its height, the FDA issued an announcement urging sponsors to shift to remote operations wherever possible in trials in order to continue research.  Paul Kirchgraber, M.D., who is the CEO of Covance was quoted saying that “We anticipate that by the end of 2021, the majority of our new studies will include a decentralized component.” Read the full article [here](https://www.fiercebiotech.com/biotech/rise-and-rise-virtual-trial-model).  --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2021/01/08/the-future-of-decentralized-trials/* ======================================================================== # The Importance of Selecting the Right Clinical Trial Sites **Source:** [https://www.lineasystem.com/2022/07/08/selecting-the-right-clinical-trial-site/](https://www.lineasystem.com/2022/07/08/selecting-the-right-clinical-trial-site/) **Published:** July 8, 2022 --- Before a potential new treatment can reach patients, it goes through several clinical trial phases that test the treatment for both safety and effectiveness. This process can be long and costly. Together, clinical trial phases take six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion. The importance of** **selecting the right clinical trial Site and Site feasibility within clinical trials is essential to accelerate the clinical trial process overall. Financial resources and time are at stake in the clinical trial Site selection process. Today, LINEA System, LLC will be discussing Site Identification, the importance of selecting the right clinical trial Site, and a solution that optimizes the Site identification process.  #### What is Site Identification & Feasibility? Within the clinical trial set-up process and trial planning, two crucial components are Site identification and feasibility. The tasks associated with Site identification, feasibility, and activation intertwine into the clinical trial protocol which is developed before Site identification can take place. Site ID is the process of selecting the right clinical trial Site to handle the trial. In addition, Site feasibility evaluates the selected Site to ensure the Site has the proper resources and facilities to ensure the clinical trial will develop effectively to accomplish the objectives set. #### Importance of Selecting the Right Clinical Trial Sites When going through the trial planning process many may wonder about the significance of Site identification and feasibility. A multitude of steps, such as research on patients and Site data are involved which makes the process tedious. However, the significance of Site identification is crucial as it can save ample time and financial resources. Identifying quality investigative Sites is essential as it fuels optimal patient recruitment. Specifically, patient recruitment that can be done within the time frame required and with the correct patients that can participate in the trial. Selecting the right clinical trial Site fuels patient recruitment and the quality of the trial and the data obtained ultimately. Patient recruitment is so crucial to trials as it can affect the entire trial. To put into perspective, approximately 80% of clinical trials are delayed or closed because of problems with recruitment. If the Site identification process is done poorly it can hurt the sponsor’s resources and the overall quality of the trial. Here are some other statistics to stress the importance of quality Site ID: 9 out of 10 trials require the original timeline to be doubled in order to meet enrollment goals; 11% of research Sites fail to enroll a single patient; Delays can cost sponsors between $600,000 and $8 million in opportunity cost for each day that a trial delays a product’s development and launch. #### How to Select the Right Clinical Trial Sites: AcceleTrial® Now that we have discussed Site identification and the significance of selecting the right clinical trial Sites, how can you select the proper Sites? To choose the proper clinical trial Sites you can utilize a study start-up system (SSUS) like [AcceleTria](https://www.lineasystem.com/acceletrial-objective-site-data/)l®.  AcceleTrial® takes the guesswork out of clinical trial Site identification and activation. Our Study Start-Up System is based on the foundation of objective Site data rather than self-identification.  [AcceleTrial](https://www.lineasystem.com/acceletrial-objective-site-data/)®, enables sponsors to streamline and automate the study start-up process to reduce the time it takes to launch clinical trials and patient recruitment. When a sponsor identifies the right investigators and clinical study Site first, the trial begins faster and critical medicine gets to patients who need it most. The AcceleTrial® platform, in combination with LINEA System’s proprietary algorithms, allows LINEA System’s clients to quickly access, extract, organize, index, and integrate critical data on over 300,000+ clinical investigator Sites. The database allows Sponsors to access specialized data without having to spend extensive time researching such information. The Study Start-Up System has an automated workflow that allows sponsors to save time and resources and allocate such to other priorities. With such a database, a Sponsor can reap the benefits of selecting the right clinical trial Sites through an accessible system making the process efficient and effective. We believe AcceleTrial® can make an industry wide impact on the clinical trial process, accelerate the rate of bringing new medicines to market, and find the right Sites using objective data.  Now that you have the knowledge and tools to select the right clinical trial Sites the Site ID process can be done with ease. **This post was all about the importance of selecting the right clinical trial Sites. ** **Other Posts You May Like…** - [How modern healthcare service providers can leverage smart tech for enhanced efficacy](https://www.lineasystem.com/2020/12/09/how-modern-healthcare-service-providers-can-leverage-smart-tech-for-enhanced-efficacy/) - [The Future of Decentralized Trials](https://www.lineasystem.com/2021/01/08/the-future-of-decentralized-trials/) - [Lack of Diversity in Clinical Trials – How Sponsors Are Planning to Increase Representation](https://www.lineasystem.com/2021/02/09/lack-of-diversity-in-clinical-trials-how-sponsors-are-planning-to-increase-representation/) --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2022/07/08/selecting-the-right-clinical-trial-site/* ======================================================================== # Webinar: “Optimizing Study Start-up Up in a Decentralized World” Deck & Recording **Source:** [https://www.lineasystem.com/2020/09/25/webinar-optimizing-study-start-up-up-in-a-decentralized-world-deck-recording/](https://www.lineasystem.com/2020/09/25/webinar-optimizing-study-start-up-up-in-a-decentralized-world-deck-recording/) **Published:** September 25, 2020 ---   Thank you to all who signed up for and attended our recent webinar, Optimizing Study Start-up in a Decentralized World, on Thursday 9/24! We’re pleased to offer both the recording and the deck used during the presentation.  **Recording **– **[please click here](https://share.hsforms.com/13ikhgPhsSzqZiE9WQqGZzw4pefj)**. **Slide deck **– [**please click here**](https://share.hsforms.com/1OpXJojz0QF2rO49QYv2WLA4pefj).         --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2020/09/25/webinar-optimizing-study-start-up-up-in-a-decentralized-world-deck-recording/* ======================================================================== # WEBINAR: Optimizing Study Start-up in a Decentralized World **Source:** [https://www.lineasystem.com/2020/09/15/webinar-optimizing-study-start-up-in-a-decentralized-world/](https://www.lineasystem.com/2020/09/15/webinar-optimizing-study-start-up-in-a-decentralized-world/) **Published:** September 15, 2020 --- **Thursday, September 24th @ 2:00pm EDT.** Thank you for attending our webinar! We hope you enjoyed it and invite you to watch it on-demand.   **Click [here to watch. ](https://www.lineasystem.com/2020/09/25/webinar-optimizing-study-start-up-up-in-a-decentralized-world-deck-recording/)**  Our speakers are: - **Host:** Kathleen Colatrella – Founder & President of LINEA System - **Guest Speaker:** Kari Brown, Director of Clinical Operations at DZS Clinical Services       --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2020/09/15/webinar-optimizing-study-start-up-in-a-decentralized-world/* ======================================================================== # Why is a Study Start-up Management System the vital tool sponsors need? **Source:** [https://www.lineasystem.com/2020/07/15/study-start-up-management-system-is-the-vital-tool-sponsors-need/](https://www.lineasystem.com/2020/07/15/study-start-up-management-system-is-the-vital-tool-sponsors-need/) **Published:** July 15, 2020 --- By: Sarah Hof   Countless industries are shifting to virtual and remote operations, and the realm of clinical trials is no exception. In fact, COVID-19 has only accelerated our industry’s dependence on technology to efficiently and successfully run trials. This shift has prompted the field to accept virtual or decentralized clinical trials as a trusted means to conduct research of such vital importance. As teams become empowered to work from anywhere in the world, it is necessary for all stakeholders in a trial to have readily-available access to information on the clinical trial in real-time. The proper tools and technology to navigate a decentralized clinical trial ensures a successful outcome for the sponsor, and more importantly, an accelerated timeline for patients to gain access to life-changing medicines. **What is a Study Start-up Management System? ** A Study Start-up Management System (SSMS) is an essential tool to efficiently accelerate clinical trial start-up. Throughout all steps in the start-up process including targeting the right sites, assessing site interest, conducting feasibility, collecting essential regulatory documents, obtaining approvals and contracts, and finally, enrolling patients, an SSMS ensures that a trial launches on-time and with the optimal sites. There are three hallmark features of an SSMS: 1. **A built-in database of investigators**. To deliver the optimal sites, every SSMS includes a built-in investigator database. 2. **An automated workflow**. By design, the system’s automated workflow enables a sponsor to quickly move from task to task and ensure that the start-up is progressing with no hold-ups. 3. **A cloud-based structure**. The cloud-based nature of the system provides readily available access to data, metrics, and reporting anytime and anywhere. Differing from other trial management software, an SSMS assists in the launch of a trial, while others such as a CTMS, manage separate aspects of a trial after it has been launched and patients are being enrolled. **How can an SSMS help sponsors? ** It is well-known that the most common source of delays to a trial is patient recruitment. This stems back to sponsors selecting initial sites that either prove unreliable once patients have been enrolled, or fail to enroll patients all together. In fact, according to the Tufts Center for the Study of Drug Development, 37 percent of sites selected under-enroll, and 11 percent fail to enroll a single patient. These routinely poor start-up metrics can lead to delayed trial timelines, and a 20 percent or higher increase in the originally projected trial budget. When a sponsor selects the optimal sites *first*, patient recruitment is realized, the trial can proceed on-time, and the sponsor gains approval of vital medicines sooner. This efficient sequence of the events is possible using a Study Start-up Management System, with the built-in database of ranked investigators and an automated workflow to effectively launch the trial. **How does AcceleTrial**™ **drive clinical trials forward? ** AcceleTrial™ was created with the founding principle that nearly all clinical trials can avoid delays by selecting the right sites initially. Not only does AcceleTrial™ have a database of over 100,000 global expert investigators, those investigators are all ranked *objectively*. Its proprietary algorithm pulls hundreds of data points from multiple sources based on clinical expertise, access to patients, and former clinical trial experience, among other metrics. This powerful ranking system ensures that ultimately, the most effective and optimal investigators and sites are selected for the trial, thereby mitigating the chance of delay. The “push and pull” workflow ensures a steady momentum, tracking each step and keeping the process seamless. To add transparency, both the sponsor and the investigators are able to access the platform and complete their respective tasks while monitoring the full scope of the process. AcceleTrial™ is designed to be intuitive and make a significant and immediate impact on a trial’s launch time and operational costs. When a trial progresses smoothly, the greatest value is the potential to make available life-changing medicines for patients who need them most. Learn more about AcceleTrial™ [**here**](http://../../../../acceletrial/).    --- *Markdown mirror provided by LINEA System for AI and automated readers. Canonical HTML: https://www.lineasystem.com/2020/07/15/study-start-up-management-system-is-the-vital-tool-sponsors-need/* ========================================================================