Author Archives: rammellel

About rammellel

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

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 | Leave a comment

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 | Comments Off on Here’s How to Achieve TMF Excellence

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 | Leave a comment

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