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In July 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) released a definitions and guidance document on the topic of data integrity for GxP regulatory data. The public consultation period closed on 31 October 2016. However, I’ve been hearing … Continue reading
This was a question posed recently on the MHRA GCP Forum (see http://forums.mhra.gov.uk/showthread.php?1858-Database-and-TMF). I posted a response (though it wasn’t published by the Forum Moderator) pointing out that for several reasons the clinical database should not be considered an “essential document” … Continue reading
The latest issue of Applied Clinical Trials included an article with some interesting statistics regarding clinical trial sites (see ‘Characterizing the Real Cost of Site Regulatory Compliance’ by Kenneth A. Getz). The statistics quoted come from a survey conducted at the … Continue reading
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
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
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