Category Archives: Uncategorized

EMA Publishes TMF Guidance

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

Posted in Regulations, TMF, Uncategorized | 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

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

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

Update: EMA Reflection Paper on Trial Master Files

A while ago I posted information here regarding the draft reflection paper from the EMA on trial master files (TMF). At that point, the intention was to bring the contents of the reflection paper along with other related guidance into … Continue reading

Posted in Uncategorized | Leave a comment

Case study-led agenda develops for TMF Europe

If you work with Trial Master Files, you might be interested to hear about IQPC’s TMF Europe conference. Now in its second year, this is highly interactive and case study driven. The agenda does away with your usual mix of classroom-style … Continue reading

Posted in Uncategorized | Leave a comment

Wingspan eTMF

We are pleased to announce the addition of Wingspan eTMF to our list of featured advertisers. Wingspan – founded in 1996 by CEO Troy Deck – has been in the electronic document management business for many years, with its suite … Continue reading

Posted in Uncategorized | Leave a comment