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International Clinical Trials

Protected and Prepared

The European clinical research industry is in a period of great uncertainty. As it reckons with current trends – such as a decline in favourability as a clinical trial destination in favour of the Asia Pacific (APAC) region and other geographies – it is simultaneously bracing itself for other changes on the horizon. These upcoming changes are largely regulatory in nature; new regulations are related to advanced therapy medicinal products (ATMPs) and medical devices, which could both add and relieve headaches for researchers (1). Also, the new Clinical Trial Regulation is coming in 2019. Furthermore, after Brexit takes effect that same year, the UK may exempt itself from the Regulation, possibly creating complexities and uncertainties both there and in the post-Brexit EU (2).

Then there is the Greater Data Protection Regulation (GDPR): a vast set of rules and guidelines aimed largely at securing the personal data of EU citizens stored and processed online. While designed for the protection of Europeans, the effects of the GDPR are by no means limited to Europe: EU nationals anywhere in the world are protected by the new law – the personal data of a German citizen living and working in Australia, for example, would be covered – lending it significance on a global level. Given its breadth and its imminence (the law is set to take effect in May of this year), it behooves one to examine the context from which it emerged, as well as how the clinical research industry falls within its scope. Indeed, clinical research and the healthcare industry, at large – which stores massive quantities of personal data in formats such as electronic medical records and clinical trial databases – is bracing for the impact of the GDPR on its operations. What events set the stage for the GDPR, how will it affect Europe’s status as a clinical trial destination, and how can organisations ensure compliance?

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Mike Novotny is the founder and CEO of Medrio – a provider of cloud-based electronic data capture, eSource, and ePRO tools for clinical trials. Mike applies 20 years of experience in research and software to his eClinical Software-as-a-Service vision.

Nick O’Brien leads content marketing efforts at Medrio. At the company, he spearheads co-marketing initiatives, such as complimentary case studies with customers, and creates and commissions content for marketing campaigns. He brings years of experience in copywriting and blogging to his role and holds a BA from Kenyon College, US.

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Mike Novotny
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Nick O’Brien
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