How Recent FDA And EMA Regulations are Helping Advance eCOA And ePRO

During the initial half of 2023, both the EMA and FDA issued fresh directives pertaining to ethics committee (EC) submissions, decentralized trials, patient-oriented drug development, as well as electronic and computerized systems. Despite some of these being in draft form, this regulatory advice indirectly contributes to the advancement and improvement of eCOA usage. This is evident in areas such as upholding data quality in decentralized trials and electronically submitting to ethics committees.

In this recorded webinar, the Clario eCOA Science team shares their perspective on the novel guidance and elucidates how the amalgamation of these directives, combined with scientific insights, can empower sponsors and biotech firms to adopt a more patient-centric approach and ensure the integrity of study data within a flexible trial setting.