Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

Rammell Consulting Ltd to Close!

As many of you know, I have been a freelance records management consultant operating as Rammell Consulting since 2004. The last 14 years as a freelance worker have been very exciting times (mostly!) and has given me the opportunity to … Continue reading

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EMA Publishes TMF Guidance

After a lengthy consultation period and delays – mostly caused by Brexit! – the EMA has published its long-awaited guideline: “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)“. This replaces the previously published draft … Continue reading

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TMF. ISF. What’s the difference – Part 2

This post continues the discussion regarding the differences between the TMF and ISF (or Investigator Site File). Several years ago, I created a pictorial representation of the TMF to illustrate that the TMF was more than just the minimum list … Continue reading

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TMF. ISF. What’s the difference?

Over the last few days I’ve been seeing a few posts on LinkedIn that have been getting me a little frustrated. The reason? Poor use of terminology! Let me explain. The Trial Master File – or TMF – is defined … Continue reading

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Do You Have Records Management Problems?

If you look through my blog posts and LinkedIn updates over recent years, you’ll be forgiven for thinking that all I do is support pharmaceutical companies with their trial master files (TMFs). It is true that this has taken up … Continue reading

Posted in Compliance, Data protection, Records management practice | Leave a comment

Launch of our new Training Programme

We are very excited to announce the launch of a new series of training events. Some of you will know that we have scheduled one-day workshops on various topics from time to time but these have often been poorly attended … Continue reading

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Last call for TMF Masterclass

Last call! There’s only 3 weeks to go until our TMF Masterclass and still some delegate spaces to fill. Early-bird discounted booking closes in a few hours so please do not delay. This is not a standard presentation-style workshop. If you … Continue reading

Posted in TMF