February 20, 2024

ALG advised on national regulatory and data privacy consent requirements for clinical trials around Europe

Ioannis Stathakis and team, provided crucial support to a multinational Pharmaceutical company by advising on national regulatory and data privacy consent requirements for clinical trials around Europe. The team advised on the legal basis that national ethics committees request sponsors to use in their informed consent forms as well as the data protection roles that the clinical trial sites and sponsors assume when negotiating clinical trial agreements. By implementing this advice in its informed consent forms and clinical trial agreements, the pharmaceutical company acquired an important head start in its negotiations with authorities and clinical trial sites, thus being able to start its clinical trials according to schedule.