Many CROs and sponsors are taking the leap and adopting electronic trial master file (eTMF) systems. But what about companies working with paper study documentation? Content management expert and life sciences industry veteran Mike Coombs discusses solutions for bridging the paper-to-paperless gap while transitioning to an eTMF system.
Why are so many life sciences companies adopting eTMF systems?
Validated study documentation is essential when it comes to product approval. A single lost file could potentially delay FDA review and postpone introducing a product to the market, costing millions of dollars in the process. eTMF systems make it easier to organize study documentation as you progress through development and clinical trials. With built-in quality control and regulatory checkpoints – and the ability for authorized stakeholders to securely review files wherever they are – eTMF helps sponsors catch and correct errors in process and ensure inspection readiness every step of the way.
What challenges do CROs and sponsors face in moving to an eTMF system?
eTMF has stimulated a desire for the industry to go paperless, but for many, it’s not an immediately realistic option. We’ve seen a lot of sponsors and CROs that are still working with paper-based documentation or are in the middle of trials that began in that fashion. eTMF management can also become disjointed when research partners employ their own individual eTMF systems, with their own unique workflows and settings. Altogether, these complications create significant barriers to gathering the information assets needed for a complete and serviceable eTMF system.
What was the inspiration for BerkOne’s eTMF DocCollect solution?
First of all, we don’t consider paper a dirty word at BerkOne. For many businesses, paper is a deep-rooted part of their processes – that doesn’t mean these companies are working in the Stone Age. eTMF DocCollect was envisioned as a way for life sciences companies to efficiently and accurately intake study documents from any source, in any format, for input into their eTMF systems.
Using this platform, documents are imaged using industry-leading virtual rescan (VRS) capabilities, which deliver consistently high-quality document images regardless of the original documents’ condition. Then, using optical character recognition (OCR), data can be extracted, and digital documents can be standardized, grouped, and prepared for injection into an eTMF system.
What are the benefits of outsourcing document management for eTMF?
The business of developing a new therapeutic is complex. That’s why there are countless CROs; it would be too costly to recruit a team and maintain an infrastructure that accounts for every specialty. Document management is no different. Instead of dedicating resources to upgrading costly in-house technologies, scanning and organizing documents, and tracking down missing information, a solution like eTMF DocCollect allows sponsors to focus on FDA/EMA submission, with peace of mind that study documentation is validated, compliant and audit-ready. As content management experts, we have helped companies in industries spanning banking to healthcare overcome the challenges of paper-native files to advance business processes and embrace electronic workflows and communications.
Ready to streamline study documentation and simplify your eTMF process? Learn more about BerkOne’s eTMF DocCollect solution.