The Veeva 2016 Paperless TMF Survey assesses the life sciences industry’s use and progress in streamlining clinical trials and unifying clinical operations. Results include the experiences and opinions of 217 trial master file (TMF) owners in an effort to understand the impact of electronic trial master file (eTMF) adoption on broader clinical processes as well as the drivers, benefits, and expectations of eTMF solutions. This is Veeva’s third Paperless TMF Survey, and while a wide variety of methods for TMF management remain, adoption of advanced, purpose-built eTMF applications has accelerated amid an industry-wide drive to improve inspection readiness and shorten clinical trial times.

Key Findings
• Adoption of advanced eTMF applications has doubled since 2014. One in four (24%) sponsors now use a purpose-built eTMF application (up from 13%) while the use of local file systems as an eTMF dropped from 26% to 8%.

• Over the same period, clinical operations departments at sponsor organizations have cut the use of paper for most/all TMF documents from 41% in 2014 to 28% today.

• Electronic collaboration with partners has increased and a quarter (23%) of sponsors now use their eTMF application to share TMF documents with CROs, up from 14% in 2014.

• Most (80%) with an eTMF application now provide remote access to inspectors/auditors.

• Consistent with the growing demand to unify clinical processes, half (49%) of sponsors say integrating their eTMF application with their clinical trial management system (CTMS) is a key need in an effort to go paperless.

• The top business drivers motivating sponsors to move to eTMFs are improving inspection readiness (67%), speeding study startup (53%), and remote oversight of the TMF (48%).

• Those who have adopted eTMF applications in particular, report improved audit and inspection readiness (61%), improved central and remote monitoring (59%), and better visibility into performance metrics (55%). Those using other types of eTMF systems are significantly less likely to see these benefits.
 
The survey comprised 13 questions designed for individuals with knowledge of TMF document processes and with partial or full responsibility for a TMF within their organization. The survey was commissioned by Veeva Systems and conducted by Fierce Markets.