Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

Posted in e-records, Regulations, TMF | Leave a comment

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

Posted in Regulations, TMF | Leave a comment

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

Posted in TMF, Training | Leave a comment

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

Here’s How to Achieve TMF Excellence

Since becoming a freelance consultant in 2004, I have been involved with around 50 different projects to improve practices for managing clinical trial records (aka the trial master file or TMF). In many of these, the company concerned had chosen … Continue reading

Posted in e-records, TMF, Uncategorized

Ready for a TMF Masterclass?

After a break of almost two years, we are planning to schedule another TMF Masterclass. Is this something that you or a colleague would benefit from? If so, please read on. This will be an intensive 1-day, interactive workshop for … Continue reading

Posted in Uncategorized