Paperless and Beyond: The Industry’s Move to Fully Electronic Trials
The just-released Veeva 2014 Paperless TMF Survey shed some much-needed light on just how far the industry has moved toward a fully paperless trial. This research into the current state of TMF ownership found that adoption of purpose-built eTMF systems is just beginning. Some 60% of respondents reported exchanging TMF documents with external parties via paper shipments or email. And while eTMFs are popular among sponsors internally, 44% of those eTMFs are simple local file systems or cloud file shares. These are simple file shares, with no built-in recordkeeping or tracking, and little in common with a process-driven eTMF application built on a regulated content management platform.
The benefits of a centralized eTMF for the purposes of visibility, efficiency, and ease are key to ensuring successful trials. Results from the benchmarking survey only reinforce this sentiment: TMF owners report significant business benefits and improvements in their TMF quality across the board. Those with the most advanced type of eTMF were more likely to report these boons.
Ninety-six percent of TMF owners leveraging an eTMF application reported one or more of the following: easier collaboration, improved audit-readiness, cost savings, better visibility, increased SOP compliance, and/or shorter clinical trials. The more advanced their eTMF technology, the more consistently benefits were reported. Those with eTMFs applications reported good or major improvements in misfiled, missing, duplicate or expired documents, missing signatures, and suggested corrections not being completed. And when eTMF applications are delivered in the cloud and designed to meet life sciences companies’ requirements out-of-the-box, many of the traditional barriers to adopting new technology are drastically reduced.
Barriers to going paperless rated as “major” or “insurmountable” boiled down to cost, compliance concerns, and lack of internal technical knowledge. But the motivators for eTMF adoption cast these in a different light. Despite 38% of respondents citing cost as a barrier to adoption, 56% reported cost savings as a driver for adoption. Furthermore, cloud-based applications are available today created specifically to address global compliance requirements, including the FDA’s 21 CFR Part 11, and support emerging regulatory trends. These solutions enable secure access for all partners and health authorities, easing compliance with new guidance from the MHRA that requires the ability to audit the TMF remotely. This is becoming an important focal point for the industry, as the survey reveals the number of sponsors that plan to provide auditors with remote access to their eTMF is set to double in 2015. Precision, tailored eTMFs delivered in the cloud, therefore, don’t just meet barriers head on—they help surpass the obstacles.
To learn more about the industry’s progress toward paperless trials, be sure to read the full findings from the Veeva 2014 Paperless TMF Survey – the largest TMF survey to date.