Tag: pharma
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…
13 Oct, 2021
eTMF & Clinical Trial Glossary
When working in the field of life sciences and even more so in clinical trials, there are many terms and acronyms you’re likely to come across but…
24 Sep, 2021
Regulation EU 536/2014: A Records Manager and Archivist’s Perspective
In April 2021, the European Medicines Agency Management Board confirmed that the Clinical Trial EU Portal and Database (a key component of the Clinical Trial Information System…
03 Aug, 2021
Three key data considerations of decentralised clinical trials
So far in this mini blog series we’ve had a look at what decentralised clinical trials (DCTs) are, explored how COVID-19 forced an accelerated adoption of them…
20 Jul, 2021
Three key benefits of decentralised clinical trials
An estimated 80% of non-COVID-19 trials were paused or cancelled as a result of the pandemic. That means that 1000s of trials and drug developments have been…
