Checklist: Essential Features Of A Future-Proof Automated eTMF System

Managing the Trial Master File (TMF) is one of the most critical and challenging aspects of running a successful clinical trial. In fact, the February 2021 inspections report from the UK health authority reveals that TMF essential documents caused the most findings within commercial sponsor organizations for the past 10 years.

Despite the growing number and variety of clinical endpoints and cross-functional collaborations in today’s clinical trials, many biopharmas and CROs are still relying on the same decades-old tools to manage the TMF. Legacy systems using outdated file sharing technology and homegrown systems using spreadsheet trackers or paper result in critical data and essential documents falling through the cracks.

Today’s Clinical teams need a collaborative solution— flexible enough to fit their workflows and accommodate contributions from sponsors, investigators, CROs, institutions, and other stakeholders, but reliable enough to ensure the TMF meets regulatory standards. The first wave of electronic TMF (eTMF) systems was a step in the right direction, but they fell short of delivering compliance for collaborative research teams, as evidenced by the 10-year trend of rising inspection findings.

As you evaluate a new eTMF solution, use this checklist to ensure the one you choose has the essential functions and capabilities you need to deliver comprehensive and compliant TMFs – now and into the future.