Decentralised clinical trials: opportunities and challenges

Elisa Stefanini has an extensive experience in regulatory and compliance matters with a particular focus, in the last years, on all legal matters regarding pharmaceuticals and medical devices and other areas of Life Sciences. Her experience includes clinical trials, placing on the market, promotion and advertising of pharmaceuticals and medical devices, etc. She has also gained significant experience in matters of protection of personal data in the context of clinical trials, with particular regard to the processing of genetic data, including through biobanks. In addition, she often advises on Life Sciences regulatory matters in the context of M&A transactions. Elisa is ranked by Chambers Europe 2024, by The Legal 500 EMEA 2024, and by Who’s Who Legal in the Life Sciences 2024 and the Italy 2023 guides. She is the author of several publications in the field of biotechnology and scientific research. She is also author of numerous articles in magazines, including foreign ones, specialized in the life sciences sector. She participates in the capacity of speaker in numerous conferences and seminars in the field of Life Sciences.

Pamela Tenaerts is Chief Medical Officer at Medable, Inc.  Dr. Tenaerts leads efforts to drive responsible adoption of research methodologies with evidence-based metrics and best practices.  Dr. Tenaerts joined Medable from Duke University, where she led the Clinical Trials Transformation Initiative’s (Public Private Partnership co-founded by Duke University and the Food and Drug Administration) efforts to develop and drive adoption of practices that increase the quality and efficiency of clinical trials. She is a member of the Drug Forum at the National Academies of Science, a Dime Founding Members Council member , a Board Member of the MedStar Research Institute and a member of the PCORI Clinical Trials Advisory Panel. Tenaerts is one of the leading advocates for innovation in clinical trials, with an emphasis on technology, protocol design and QbD, patient engagement, responsible evidence generation and clinical trial methodology improvements. With more than 30 years’ experience in the conduct of clinical trials across a number of stakeholders, she practiced medicine in both the emergency department and as a family practitioner in the private practice setting before embarking on a career in research.   She received her MD from Catholic University of Leuven, Belgium, and a MBA from the University of South Florida.  She speaks multiple languages