Category Archives: TMF

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

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When is a CSR a TMF?

It appears that the anxiety within the industry regarding the proposed Trial Master File retention requirements in the draft EU Clinical Trial Regulation may be unfounded. Earlier today I had the pleasure of meeting Mrs. Marina Yannakoudakis MEP at her … Continue reading

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Clinical Trials EU Regulation – Even More Bizarre

Following the recent vote of the ENVI Committee on the several hundred amendments put forward to the proposed EU Clinical Trial Regulation, the consolidated report containing all carried amendments has now been published. Report A7-0208/2013 entitled “Report on the proposal for a … Continue reading

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Clinical Trials EU Regulation – An Update

You will remember that I wrote a few weeks ago about the proposed Clinical Trial Regulation which will replace EU Directive 2001/20/EC. Specifically, myself and many of my industry records management colleagues were extremely concerned about Amendment 60 which was … Continue reading

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An eTMF is For Life, Not Just For Christmas! Achieving Archive Compliance

This is the title of the next webinar that we are involved with. This topical webinar will be structured as follows: Karen Redding of Phlexglobal will present the current eTMF industry status and how eArchiving is not being addressed;     Eldin … Continue reading

Posted in e-records, Technology, TMF, Training

Should Legislation Mandate Specific Minimum Retention Periods for Documents?

If we consider a variety of legislation on the statute book in the UK for example, it is more often the case that citizens and corporations are left to define their own retention period that is consistent with both the … Continue reading

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