Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

MHRA Publishes Latest GCP Inspection Findings

The MHRA today released on their website their annual report of GCP inspection findings. It is interesting to note two critical findings for data integrity issues…. something that industry has been talking much about over recent months. It would be … Continue reading

Posted in Regulations, TMF | Leave a comment

What’s in a name?

“A rose by any other name would name would smell as sweet” is a frequently referenced quote from William Shakespeare’s Romeo and Juliet…. meaning that the name is not as important as the object itself. This blog post is a … Continue reading

Posted in Records management practice, Training | Leave a comment