regulatory compliance Archives - Arkivum

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12 Oct, 2021

Webinar Discussion: The meaning and impact of Regulation (EU) 536/2014

Whitney Armstrong

Wednesday 27th October, 2pm BST, 9am EST We’re delighted to invite you to this month’s webinar on Wednesday 27th October at 14.00hrs (BST) in which we shall…

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…

02 Jul, 2021

COVID: The catalyst of decentralised clinical trials?

Harriet Clark

The clinical research industry is one of many rules, regulations, processes, systems, privacy requirements and much, much more – for good reason. The safety of the patient,…

28 Jun, 2021

What options do CROs and Sponsors have for managing trial data at the end of a trial?

Russell Joyce

Long ago, the concept of outsourcing clinical studies began to trend within clinical research and today, has become a customary business strategy that is widely accepted and…