What US biotech companies need to know before taking clinical trials to Europe

Oct 30, 2019

KCR’s Legal Counsel weighs in on importance of data protection

Posted by KCR, US

Boston, October 29 2019 – Outsourcing clinical trials internationally has often proven to be a successful endeavor. However, the process involves a lot of considerations, including European data protections regulated by General Data Protection Regulation (GDPR,) which took effect in May of 2018. The regulations require US companies that conduct clinical trials in Europe to protect the personal data of patients throughout the life of the study.

KCR, a clinical development solutions provider, having its operations across Europe and North America, has mastered the regulatory and operational challenges of international clinical trials. KCR’s Legal Counsel, Agnieszka Felicjanczuk clarifies one of the main misconceptions noting, “GDPR is applicable not only to companies based in EU, but also to all organizations outside EU that offer products or services or monitor behavior of individuals in the EU.”

What does this mean for clinical trials? Any US company that conducts clinical trials in the EU must follow GDPR and protect personal data of patients throughout the life of the clinical trial accordingly. This includes general, personal data as well sensitive, medical data. Under GDPR regulation, even pseudonymized data is considered personal data and must be subject to protections.

“As a clinical trial sponsor, the company must first assess their data processing activities to determine what data will be collected, who will have access and how it will be protected,” explains Mrs. Felicjanczuk. “Additionally, they will need to make sure that data processing agreements are in place where needed and the information obligation is performed towards all data subjects concerned.”

KCR recently hosted a seminar named “GDPR: What does U.S. biotech need to know before executing clinical trials in Europe?” The event was created for the life science community in Boston to discuss the most important things to know about GDPR before executing clinical trials in Europe. If you would like to receive the full presentation from this seminar,  please contact Molly Garrity, PR & Marketing, at molly.garrity@kcrcro.com with your full contact details.

About KCR:

KCR is a clinical development solutions provider for the biotechnology, pharmaceutical, and medical device industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.

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