Trial Data Exchange: A Site-Centric Approach to Standardizing Regulatory Management

Stuart Cotter
Director of Product Success, Forte
January 10th, 2019

During our recent Steps to Transform Clinical Research Through a Site-Centric Approach webinar, Forte’s Founder and CEO Shree Kalluri and Chief Product Officer James Wurdeman outlined their focus on increasing industry-wide efficiencies with Trial Data Exchange (formerly known as DIRECT), which ties together standards-based site portfolio technology and connections with sponsors and CROs. Trial Data Exchange will create a two-sided network where systems used to collect clinical data and optimize research performance are connected and channel information to stakeholders for more efficient and higher-quality clinical trials.

Trial Data Exchange: Regulatory Management

One aspect of the Trial Data Exchange concept will target regulatory documents. At best, today’s process involves sponsors and CROs emailing documents to each research institution throughout the lifecycle of the clinical trial—or, more commonly, relying on sending hard-copy binders that are then scanned into the site’s electronic regulatory system. In turn, the research institution distributes the paper documents, only to collect them again to manually send back to the sponsor. This process is time consuming for all stakeholders and requires tracking and updates in multiple systems. In addition, this approach can lead to misinterpreted timeline requirements, unneeded check-ins on completed activities, and misfiled documents that can slow study activation and increase compliance risks.

Sponsors and CROs have expectations for how the regulatory binder is structured and the timelines associated with protocol milestones at each research institution. As new investigator brochures, IND safety reports, protocol amendments and other regulatory documentation is required, Trial Data Exchange makes it easier to transmit critical updates to participating research institutions. In addition, instead of having additional processes and separately-maintained project schedules for defining these structures and schedules, sponsors and CROs will be able to use Trial Data Exchange to set up clear structures and document timeline expectations during study activation. Along with increased efficiency, it will provide a consistent, traceable communication method through the entire clinical trial, which increases patient safety, reduces compliance risks and supports remote monitoring and lower monitoring costs.

A Site-Centric Approach

Large research institutions manage hundreds or thousands of clinical trials simultaneously. By focusing on a site-centric approach, Trial Data Exchange standardizes how regulatory documents and requirements are received across the site’s entire portfolio. This method ensures effective standard operating procedures for documents and supports the ability meet study activation timelines. Regulatory documents stored in the investigator site file (ISF) will be instantly exchanged to the sponsor or CRO’s trial master file (TMF) after review, approval, and electronic signature is obtained from the research institution’s eRegulatory system. This includes protocol documents as well as electronic logs (such as Delegation of Authority, Subject Enrollment) managed in the research institution’s eRegulatory system, which will automatically update the sponsor or CRO system to stay in sync.

Beyond protocol-specific document efficiencies gained, the site-centric approach also streamlines updates to key information that is already managed centrally within the connected research institution’s eRegulatory system, such as:

  • Up-to-date credentials from the research staff such as medical licenses, CVs, and human subjects trainings
  • Institution-specific laboratory certificates (CLIA, COLA)
  • Local IRB rosters and registrations

These documents are then updated and available for immediate transfer to the sponsor or CRO once updated and the collected from the research staff throughout the trial.

Streamlining the Monitoring Process

Effective monitoring is critical to ensuring high-quality trials. By exchanging these documents directly from the site’s ISF to the sponsor or CRO’s TMF, Trial Data Exchange will enable faster review of incoming documents and expedite corrective action sent to the research institution. This will enable both a risk-based and remote approach to monitoring regulatory documents, reducing both costs and delays.

Building a Foundation for Success

Our first stage in creating Trial Data Exchange for a connected TMF and ISF workflow is nearing completion. This phase includes the ability for electronically-signed documents to be directly transferred to the sponsor or CRO’s TMF for acceptance. The document transfer will seamlessly integrate both stakeholders’ regulatory systems to ensure compliance and respect for mutually-agreed-upon timelines.

By connecting regulatory systems, Trial Data Exchange will allow research institutions to use the same system for all clinical trials and to receive consistent communication about studies and timelines. Taking this approach as opposed to a trial-specific regulatory system, the site can manage their entire clinical research portfolio using their existing infrastructure and follow the same sets of institutional standards. In turn, sponsors and CROs will gain visibility into study activation, decrease time spent administering documents and timelines, and reduce compliance risks by having one communication avenue to use to send critical updates. These improvements create a win-win-win ecosystem with more efficient communication and higher-quality clinical trials for sponsors, research institutions, and ultimately, clinical trial participants.

This post is the first in a series focused on inverting the clinical research industry by creating a site-centric connected clinical research ecosystem, interconnecting all stakeholders. Check in next week to see how we’re working to provide real-time accrual and subject visit analysis to improve data quality and reduce the administrative burden for both sites and sponsors.

Clinical Research Technologies Compliance and Regulatory Efficient Clinical Trials