The TMF has historically been composed primarily of paper documents, images in physical file cabinets.
In order to lower costs and to expedite the clinical trials approval processes, government agencies involved in regulating clinical trials such as the U.S. FDA and the EMA have been developing technology for the same.
This would also lower the costs of the approvals of clinical trials processes.
In the U.S., the FDA created regulation CFR 21 Part 11 which supports the use of electronic records, digital media and digital signatures in clinical trials. In Europe, the European Medicines Agency has issued policies that support the use of digital signatures in clinical trials.
In clinical trials and healthcare, enterprises with manual paper-based systems are seeking to transition to automated electronic system to ensure higher levels of regulatory compliance for reducing business risk.
FDA’s Part 11 policy helps clinical trials to move from a paper-based TMF to an electronic TMF (eTMF), and still be in compliance with regulatory policies.
eTMF contain digital documents in their original format, potentially with digital signatures, or records that have been converted from another format, such as paper documents that has been converted to digital images, which may contain wet-ink signatures. The metadata applied to documents is recommended be formally defined to ensure consistency across all documents.
To ensure Audit compliance and readiness it is necessary to have proper management of the trial documents.
The core requirement for any eTMF solution should be Archiving of the digital trial documents, Audit trails for each an every activity done,
Access control to the users as per the companies SOP and System validation.
So to allows life sciences companies to efficiently perform the processes, smoothly interchange of information and reduce the administrative overhead associated with running clinical trials it is important to have eTMF solution in hand with all the key benefits.
The Sarjen – Electronic Trial Master File (eTMF) solution is a platform to manage trail documents.
Key Features of Sarjen – eTMF
- Readiness for the Audit throughout the trial. Keeps TMF up-to-date in a single source for all the stakeholder like sponsors, Inspectors for audits, CROs and Sites
- Enhancement in productivity by replacing manual processes with accurate electronic processes
- Multi structure for Early phase as well as Late phase trials in a single source
- Managing Metadata for each document and Audit trial for the same
- Unique profiles for all the stakeholders
- Faster document searching and retrieval