Author Archives: rammellel

About rammellel

Records, information and quality management consultant to the life sciences / pharmaceutical industry

Rammell Consulting Ltd to Close!

Posted on February 18, 2019 by rammellel

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

Posted on December 18, 2018 by rammellel

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

Posted on November 12, 2018 by rammellel

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?

Posted on November 9, 2018 by rammellel

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?

Posted on July 20, 2018 by rammellel

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