Tag: TMF
17 Jan, 2022
Why is the transfer of your eTMF from CRO to Sponsor so vital?
So, your study is complete. All the documents have been recorded and collected. Completeness is at 100%. You‘re ready to move on to the next study. But…
16 Dec, 2021
My take-aways from the TMF & GCP Inspection Readiness Forum
A few weeks ago, I had the opportunity to attend the TMF & GCP Inspection Readiness Forum and listen to some of the smartest people in our industry…
07 Dec, 2021
Our top 15 EU Regulation 536/2014 questions – Part 2
Following on from our first instalment of regulation 536/2014 questions, we bring you part two in which we delve into more intricate questions asked by CROs and…
02 Dec, 2021
Our top 15 EU Regulation 536/2014 questions – Part 1
EU Regulation 536/2014 is coming into effect at the end of January 2022. As we approach the date, we are seeing an increase in the number of…
27 Oct, 2021
Panel Discussion Recording: Unlocking the long-term potential of clinical data
We’re delighted to bring you the recording of an insightful and exciting panel discussion. On Wednesday 20th October, in collaboration with Marcus Evans, we brought together several…
14 Oct, 2021
What is the Exchange Mechanism Standard (EMS)?
As a follow-up to last week’s blog instalment about the TMF reference model, we will now discuss the exchange mechanism standard (EMS). The EMS was developed by…