Tag: regulatory compliance
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…
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…
