Electronic trial master files (eTMFs) are digital repositories of regulated content related to a clinical trial. Their usage is on the rise, with increasing investment being made in digitization by biotech companies in the wake of the Covid-19 pandemic. Egnyte for Life Sciences can host eTMFs in a way that facilitates and expedites secure collaboration, data collection, and archiving in line with regulations.
The rise of eTMFs
The latest Industry Standard Research (ISR) survey data on eTMF usage is from 2018 and puts adoption at 75%. It is no mystery why eTMFs are so popular: they make it easier to track progress, provide more control over a ‘single source of truth’ and enable better and faster data sharing options than paper-based sources. It is one way to integrate disparate internal systems and scattered data repositories into one place, which is a key factor contributing to process optimization, according to the ISR report.
Digitization is listed as one of the top investments by biotech companies since the pandemic has interrupted most in-person study activities. Although there is no data on this yet, it is reasonable to suggest that the pandemic has bumped up the adoptions of eTMFs quite a bit more. According to PharmaManufacturing, 65% of pharma manufacturers believe that the pandemic will increase the industry’s use of technology to collect and analyze data. The range of technological tools that are deployed and their uses will become more sophisticated industry players grow more comfortable with the idea of relying on technology.
Egnyte: Modernizing workflows
Egnyte for Life Sciences has been facilitating secure file-sharing for over a decade, with a focus on accelerating the process of collaboration without compromising security. The GxP package helps life sciences organizations ensure that data handling meets 21 CFR part 11 requirements for collection and storage of regulated data and documents.
Egnyte’s platform can host an active eTMF structure. It starts with a compliance portal which is designed to provide all the documentation for validation and compliance in an easy-to-access and on-demand location. The compliance portal is comprised of a validation package, which provides the documentation associated with initial implementation, along with ongoing validation support in the form of daily production qualification reports, which prove that the system is working. Ongoing risk assessments review new features and functions in relation to CFR Part 11 requirements.
Active eTMFs contain folders, sub-folders and custom metadata for tracking artefacts and milestones. You can use the DIA Reference Model, or your own custom structure. The platform is built around secure and seamless collaboration. Access to folders and sub-folders can be controlled in a granular manner for each contract research organization (CRO) or collaborator. There are two ways to bring in content from CRO sites. The first is direct upload into the structure. Files can be easily dragged and dropped onto the platform for quick upload. The second option is by link location. CROs and other collaborators can be given an upload link through which they can drop data into the eTMF structure. This does not provide access to the account: it is a one-way data drop for sharing content.
All this is supported by Egynte’s comprehensive file audit system, which tracks all changes in given sites or trials. These audit trails allow data integrity and identity to be tracked and controlled.
Egnyte for Life Sciences is used by over 600 life science organizations to collaborate with external partners, manage regulated documents according to GxP standards and adhere to security and privacy regulations like GDPR and CCPA. As members of the life sciences industry increasingly turn to technological solutions to their challenges, it will be more important than ever to safeguard their most valuable asset, their data.