Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

EMA Publishes New TMF Guideline for Consultation

The European Medicines Agency (EMA) has published (12-April-2017) a new guideline “on good clinical practice compliance in relation to trial master files” (TMF). This guideline includes and updates the guidance issued previously in the EMA draft reflection paper on trial … Continue reading

Posted in Uncategorized | Leave a comment

MHRA Draft Guidance on GxP Data Integrity….. a Few Thoughts

In July 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) released a definitions and guidance document on the topic of data integrity for GxP regulatory data. The public consultation period closed on 31 October 2016. However, I’ve been hearing … Continue reading

Posted in Compliance, e-records, Technology | Leave a comment