Category: Blog
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…
11 Jan, 2022
What does 2022 have in store for clinical trials?
The last 12 months has seen many changes happen across the conduct of clinical trials and their subsequent inspections from regulatory authorities. In a year that has…
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…
18 Nov, 2021
Understanding eTMF and GCP FDA data retention requirements
Who is the FDA? The Food and Drug Administration (FDA) is the US regulator responsible for protecting the public health by ensuring the safety, efficacy, and security…
