Clinical trials data in Europe is more important than ever. As clinical research sponsors, whether they are biopharma sponsors, not-for-profit foundations, or academic research centers, these sponsors will collect as much data as possible covering investigational drugs and devices – not to mention any adverse effects. In parallel, a massive technological boom offers researchers heretofore inccessible “Big Data” opportunities made possible by the advent of cloud computing, data warehouse, and analytics (including AI) as well as a myriad of mobile and personalized data collection tools from smart phones to wearables. With all this data about the drug and the patient, an veritable treasure trove can be tapped into for research and development purposes. But what are the data protection and privacy obligations required via the General Data Protection Regulation (GDPR)? Patrice Navarro, counsel in the Paris office of law firm Hogan Lovells, discusses.
Follow the link to the source, JD Supra, to read this important interview on the timely topic of GDPR data compliance for clinical trials activities involving data collection and management.
Patrice Navarro, counsel, Hogan LovellsSource: JD Supra