Category Archives: TMF

TMF Benchmarking

A quick blog post today! Have you completed our TMF Benchmarking Survey? We are running a very brief online survey to identify any trends in terms of how companies are defining their TMF and how they interact with CROs with … Continue reading

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The World Slowly Wakes to the Reality of TMF Requirements

Perhaps my title is somewhat harsh but I perceive more than a little frustration in the announcement today from the MHRA that they are revising their definition of critical inspection findings to include cases “where provision of the Trial Master … Continue reading

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The Multimedia TMF Becomes a Reality

The clinical records management community is currently enjoying an interesting debate regarding the need for interoperability standards for electronic trial master file (eTMF) content. The need for organizations to efficiently exchange documents and metadata between systems is becoming increasingly critical, … Continue reading

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How to Apply a Risk Based Approach to Records Management

The European Medicines Agency (EMA) has recently published its final reflection paper on risk based quality management in clinical trials, reference EMA/269011/2013, 18 November 2013.The management of trial records is barely mentioned in the paper but I took away a … Continue reading

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UK Government Seeks to Prevent Proposed Amendment to Clinical Trial Regulation

If you’ve been following the ongoing debate regarding the proposed European Clinical Trial Regulation (see previous posts on this site), you will know that the text currently before Parliament is proposing (a) that Trial Master File content be held and … Continue reading

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Are You Thinking Big Enough?

I’ve just been reading an interesting article by Bob Kocher, a partner at healthcare investment company Venrock. He was talking about investment in digital healthcare technologies and much of what he had to say rang so true to me about … Continue reading

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Is an eTMF Standard Needed?

This is a question that many of us in the clinical document management space are currently asking ourselves following the announcement by CareLex of their intention to develop and launch an industry eTMF standard under the auspices of OASIS. There already … Continue reading

Posted in e-records, Records management practice, Standards, Technology, TMF | 1 Comment