Common Questions Guide for
AcceleTrial

AcceleTrial is LINEA's site execution and activation platform. It picks up where the Research Site Index (RSI) leaves off, taking a ranked list of candidate sites and running each one through a governed workflow that covers feasibility outreach, confidentiality agreement execution, regulatory document collection, and milestone tracking through to first patient enrolled.

Rather than relying on manual spreadsheets and disconnected email threads, AcceleTrial gives sponsors a single operational layer that tracks progress across every site simultaneously, flags bottlenecks in real time, and keeps the activation timeline on course.

AcceleTrial is fed by the RSI's site intelligence layer, which aggregates data from published trial registries, historical site performance records, investigator publication databases, and proprietary outreach history. Once a study is initiated, AcceleTrial also ingests document return timelines, feasibility response data, and sponsor-supplied protocol parameters to dynamically update site rankings and flag activation risks.

Sponsor-specific data, such as prior relationships, preferred site networks, or regional constraints, can be layered in at study setup to personalize the outputs without affecting the underlying data model.

CROs and consultants bring human judgment and relationships, which are valuable, but they also bring variable timelines, opaque methodology, and knowledge that walks out the door when a project closes. AcceleTrial is a software-driven system that documents every decision, runs outreach at scale simultaneously rather than sequentially, and produces a traceable record of why each site was selected or passed over.

LINEA does not replace sponsor or CRO clinical ops teams. AcceleTrial is designed to integrate with those teams by handling the high-volume coordination work (document chasing, follow-up cadences, milestone logging) so your team can focus on higher-order decisions.

Deliverables are structured around three phases. At study initiation, sponsors receive a ranked site list with scoring rationale, a feasibility questionnaire package, and a CDA distribution log. Mid-engagement, sponsors receive a live activation dashboard showing document status, site response rates, and projected timelines. At close, the engagement produces a final site activation summary, lessons-learned documentation, and, where applicable, a handoff package for the sponsor's CRO or internal study team to continue post-selection activities.

For studies where the protocol and therapeutic area parameters are well-defined, LINEA can typically have an initial ranked site list ready within 5–7 business days of engagement kick-off. Full AcceleTrial workflow initiation, including CDA distribution to the first wave of sites, can begin within 10 business days. Timeline varies based on indication complexity, target region count, and the number of sites in scope.

For urgent studies or those with narrow activation windows, LINEA offers an expedited mobilization path. Talk to our team to discuss your timeline.

The RSI scores each site against a multi-factor model that accounts for prior enrollment performance in the relevant therapeutic area, investigator publication history and trial experience, site infrastructure quality, patient population access, regulatory track record, and responsiveness in prior outreach. Each factor is weighted based on the sponsor's priorities for a given study; a site with exceptional oncology volume but limited phase I experience, for example, would score differently depending on the study phase.

Scores are normalized across the candidate universe so the final ranked list reflects relative performance rather than absolute ratings, which avoids bias toward large academic centers when smaller community sites may actually deliver faster enrollment.

The RSI draws from a combination of public and proprietary sources: ClinicalTrials.gov trial history, FDA inspection databases, PubMed investigator publication records, IRB and regulatory approval timelines from prior studies, and LINEA's own outreach history database built over years of active engagements. Site-specific infrastructure data, including staff size, monitoring capacity, and data management systems, is collected through structured feasibility responses and updated on a rolling basis.

No single data source drives the score. The multi-source approach reduces the risk of over-indexing on easily gamed metrics like publication count while surfacing sites with strong operational track records that may not appear prominently in academic literature.

For rare diseases, first-in-class compounds, or therapeutic areas with sparse site history, LINEA applies an adjacent-indication methodology. Sites are scored based on performance in closely related indications, including shared patient population characteristics, relevant subspecialty expertise, or comparable trial complexity, and the model's confidence intervals are surfaced explicitly so sponsors understand where the evidence base is strong versus where expert judgment is filling the gap.

In some cases LINEA supplements algorithmic scoring with targeted landscape research, including key opinion leader mapping and patient advocacy network analysis, to identify sites with emerging expertise not yet reflected in trial registries.

LINEA generally delivers a screened candidate list at a ratio of 3–4× the sponsor's target site count. If a sponsor needs to activate 20 sites, LINEA will typically screen and rank 60–80 candidates, allowing for anticipated attrition from CDA declines, failed feasibility screens, and sites that are overcommitted at the time of outreach. The list is tiered so the sponsor's team can work top-down with a clear view of which sites to prioritize for parallel outreach.

Sponsors occasionally have preferred sites, such as existing relationships, KOL-nominated investigators, or sites mandated by a regional partner, that may not appear in LINEA's initial candidate pool. These sites can be added to the workflow as sponsor-directed additions. LINEA will conduct a baseline assessment using available public data and outreach history, flag any known concerns (e.g., past inspection findings, regulatory delays), and process them through the same CDA and feasibility workflow as ranked candidates, with the understanding that their scoring rationale is advisory rather than algorithmically generated.

The outreach sequence typically begins with a study introduction letter and a Confidentiality Disclosure Agreement. Once a site executes the CDA, LINEA distributes a feasibility questionnaire tailored to the study's indication and phase. For sites that pass the feasibility screen, LINEA coordinates delivery of additional pre-activation documents such as a protocol synopsis, site qualification checklist, and, where the sponsor requires it, a site initiation visit (SIV) readiness package.

All documents are tracked at the site level within AcceleTrial, so sponsors have a real-time log of what each site has received, acknowledged, and returned.

Across LINEA engagements, ~50% of executed CDAs are returned within 7 business days of initial outreach, with ~80% returned within 21 days for well-resourced sites. Feasibility questionnaires, once distributed post-CDA, are typically returned within 10–14 business days when sites are adequately primed during the introduction call.

Sites that go silent after initial outreach receive a structured follow-up cadence at days 5, 10, and 18 before being deprioritized in favor of the next-ranked candidates. This prevents timeline drag without burning sponsor relationships at sites that may be right for a future study.

AcceleTrial runs an automated follow-up cadence for each site that is triggered by document milestones, or the absence of them. When a site has not acknowledged receipt of a CDA or returned a feasibility questionnaire within defined windows, the system generates a follow-up prompt and logs the outreach. LINEA's coordination team handles the actual contact (email and phone), while AcceleTrial timestamps every touchpoint for the audit trail.

Sites that remain unresponsive after the full cadence are marked as deprioritized, and the sponsor is automatically notified so the next-ranked site can be advanced into the outreach queue without delay.

Sponsors receive continuous access to a shared AcceleTrial dashboard during the active engagement. At defined milestone gates, typically post-CDA close and post-feasibility screen, LINEA also delivers structured summary reports that compile site response rates, score distributions, and recommended go/no-go decisions by site. Final deliverables at engagement close include a site activation summary document and a complete audit log of all outreach activity.

Reports are formatted for both clinical ops review and executive summary use. Sponsors can share the executive summary with governance boards without exposing site-level proprietary data.

The ranked site list is delivered in structured Excel format with a companion PDF summary for presentation use. Each entry includes: site name and location, investigator name and contact, RSI composite score and sub-scores by domain, feasibility response summary, CDA execution status, and LINEA's activation recommendation with supporting rationale. The Excel file is formatted to import directly into most CTMS platforms without reformatting.

LINEA's standard engagement scope covers the selection-to-activation handoff: site identification, CDA execution, feasibility screening, and delivery of a qualified site list with activation readiness ratings. For sponsors who require deeper support, LINEA also offers an extended activation track that includes regulatory document collection (essential documents package, IRB submission support), site initiation preparation coordination, and timeline monitoring through to first patient screened.

The extended activation scope is scoped separately from the core AcceleTrial engagement and is typically appropriate for sponsors without a dedicated site activation team or for studies with aggressive timelines. Contact us to discuss what is right for your study.

AcceleTrial is designed as a complement to, not a replacement for, the sponsor's CRO. The standard handoff point is the delivery of the qualified site list and feasibility report; at that stage, the CRO picks up clinical monitoring, contract negotiation, and post-activation oversight. LINEA can participate in CRO transition calls and provide data access to the CRO's project team to ensure continuity.

In some engagements where the CRO is involved from the outset, LINEA works in parallel with the CRO's site identification effort, particularly where the sponsor wants an independent validation of the CRO's site recommendations or requires coverage of geographies outside the CRO's standard network.

The standard AcceleTrial engagement closes when the sponsor has a confirmed shortlist of sites that have executed CDAs, passed the feasibility screen, and been approved for activation. This typically coincides with the sponsor's or CRO's contract initiation step. The handoff package, including site contact records, document execution logs, and feasibility response data, is transferred in full at that point.

For engagements with an extended activation scope, LINEA's involvement continues through first patient screened at each site, with milestone check-ins at protocol training completion and IRB approval.

Sites that were screened, contacted, and passed over, whether due to capacity constraints, poor feasibility scores, or sponsor prioritization decisions, are documented in the engagement record with the rationale for their exclusion. LINEA retains this data internally to improve future scoring accuracy and to flag these sites as warm candidates for follow-on studies in the same therapeutic area. Sponsors are not obligated to use these sites in future engagements, but prior outreach history meaningfully reduces cycle time on subsequent studies.

A complete study intake requires four elements: a protocol (or detailed protocol synopsis), the target therapeutic area and indication, the geographic regions in scope, and the sponsor's target site count with any hard constraints (e.g., minimum phase II experience, required IRB type, language requirements). Optional but helpful inputs include a list of sites the sponsor has worked with previously, any sites to exclude, and the planned study timeline with first patient in (FPI) target.

LINEA can begin feasibility planning from a protocol synopsis if the final protocol is not yet available, with the understanding that the site list may be refined once the full protocol is received.

The core engagement, from signed agreement to delivery of a qualified, feasibility-screened site list, typically runs 8–12 weeks for a study targeting 20–40 sites. The largest variable is site responsiveness to CDA and feasibility outreach, which LINEA actively manages but cannot fully control. Studies targeting more than 50 sites, covering multiple regions, or operating in rare indications with a limited site universe should plan for timelines at the longer end of that range.

LINEA provides a study-specific timeline estimate at kickoff based on historical data for the indication and geography, updated at each milestone gate as actual site response data comes in.

LINEA contacts sites directly on the sponsor's behalf. All outreach is conducted in the sponsor's name; LINEA's role is disclosed to sites as a service partner managing the outreach process, but communications are branded to reflect the sponsor's study and sent from an address that clearly identifies the study context. Sponsors review and approve outreach templates before distribution.

Sponsors can choose to be CC'd on all site communications or to receive consolidated status updates at defined intervals. The default configuration is consolidated weekly updates, with real-time dashboard access available throughout.

AcceleTrial is purpose-built to complement existing processes. Sponsors who have an established site network, a preferred CRO, or internal clinical ops teams do not need to displace those resources; AcceleTrial adds a structured, data-driven selection and outreach layer that makes the existing process faster and more defensible. Sponsors without internal site selection infrastructure can rely on AcceleTrial as the primary operational system for a study, with LINEA's team handling coordination end to end.

Many LINEA clients run AcceleTrial in parallel with their CRO's site identification process to cross-validate recommendations, surface sites the CRO's network may not include, and accelerate the outreach phase by starting outreach earlier in the study timeline. Request a demo to see how this works in practice.