WEBINAR: Optimizing Study Start-up in a Decentralized World

Thursday, September 24th @ 2:00pm EDT.

To register, please click here.

Our Founder & President is teaming up with the Director of Clinical Operations from one of the leading CROs – DZS Clinical Services – to talk through the challenges and opportunities of the shift towards decentralization and the new way of conducting trials. 

Anyone in the clinical trial space knows how difficult it can be to manage a team, make decisions, and drive progress to launch a trial, all while operating virtually. During this discussion, the speakers will show how sponsors can turn pitfalls and frustrations into opportunities and triumphs. 

Our speakers are:

  • Host: Kathleen Colatrella – Founder & President of LINEA System
  • Guest Speaker: Kari Brown, Director of Clinical Operations at DZS Clinical Services

LINEA System teams up with Trial By Fire in fully-integrated partnership

 

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 Management System (SSMS) 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.

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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 Management System (SSMS), 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

Why is a Study Start-up Management System the vital tool sponsors need?

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. From all steps throughout the start-up process beginning with 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 database of investigators.
  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 at all. 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 for patients in need. 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 AcceleTrialdrive 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 any 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 sites and 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.

LINEA System: Advanced Technology for Accelerating Clinical Trial Launch

 

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, 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