Twelve Months on, What Are the Implications of the GDPR on Drug and Device Clinical Trials?
Clinical trials are a critical and fundamental part of all life science companies’ operations. Data management, security, and privacy within clinical trials are important, but they're complicated.
They're complicated because of:
In this article Marsh Asia’s Life Sciences Industry Leader, Prashansa Daga, discusses the implications of the changing regulatory landscape for all players within the clinical trial supply chain.
In particular, what is the role of the European Union’s (EU) General Data Protection Regulation (GDPR) with respect to clinical trials data, and what are the responsibilities and obligations on healthcare professionals and companies using individuals’ data?
Working through a number of clinical trial scenarios and whether the GDPR may or may not apply, this piece finishes with a discussion of: