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HCL Technologies

eTMF in Clinical Trials

eTMF in Clinical Trials

An electronic trial master file (eTMF) is a system of managing electronically formatted content. It is extensively used in the healthcare and pharmaceutical industries for compilation of data in form of images, documents, and other digital content for clinical trials. An eTMF system should be 21 CFR part 11 compliant capable and mandate detailed audit of user activity on the system and throughout the process.

Document management is the most important facet of eTMF. It involves a chain of activities – creation, classification, indexing, quality control, and storage. eTMF systems cater to the entire clinical trial lifecycle. The industrial requirements are changing rampantly, and hence, a beefed-up eTMF system that ticks all the boxes is the need of the hour.

Some of the key benefits include reduction of cost of clinical trials, greater transparency and accessibility of documents for auditing purposes and enhanced productivity and quality. While there might be initial transformational hiccups, the eTMF system is a sustainable platform that is expected to reap rich dividends for companies in the long run.

Download our detailed whitepaper on eTMF for a better insight of this trailblazing innovation in healthcare and how it stands to benefit you.