regulatory compliance Archives - Arkivum

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07 Dec, 2021

Our top 15 EU Regulation 536/2014 questions – Part 2

Whitney Armstrong

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

Whitney Armstrong

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

Whitney Armstrong

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

Russell Joyce

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

Harriet Clark

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

Harriet Clark

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…