Tag: life sciences
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…
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…
12 Oct, 2021
Webinar Recording: The meaning and impact of Regulation (EU) 536/2014
Arkivum were delighted to present a webinar where we discussed the imminent implementation of Regulation EU 536/2014. We explored how this regulation will change the landscape of…
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…
