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Compliance In Focus

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Keep Your Clinical Trial Moving from a Distance

You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.

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Posted by Lisa Wickert on Tue, Apr 10, 2018

The General Data Protection Regulation: Impact on Personal Data Use in Clinical Trials

On May 25, 2018 the General Data Protection Regulation (GDPR) goes into effect in the European Union (EU). This regulation has a broad scope beyond companies performing clinical research – all personal data falls under this jurisdiction which includes web search engines, social media, and much more. But specifically, how does this new regulation affect personal data collected during a clinical trial and what do Sponsors and Contract Research Organizations (CROs) need to do to ensure compliance? Here we aim to address the highlights of the GDPR and its implications on clinical research.

Topics: European Union, EU, General Data Protection Regulation

Posted by John Lehmann on Wed, Mar 04, 2015

Is the FDA Pointing the Finger at EU’s Device Review?

Well, it’s been the elephant in the room for the industry as of late. News broke in April about a leaked internal report in which the FDA points out “12 classes of malfunctioning or needlessly invasive high-risk medical devices approved for sale in Europe but not the United States,” reports The Star Tribune article.

Topics: EU, Carl Heneghan, FDA