How the Recent FDA & EMA Regulations are Helping Advance and Enhance Electronic Clinical Outcome Assessments (eCOA-ePRO) Webinar Replay

Over the first 6 months of 2023 new guidance has been released by the EMA and FDA regarding ethics committee (EC) submission, decentralized trials, patient-focused drug development, electronic systems and computerized systems. Although some are in draft format, this regulatory guidance is (indirectly) helping to advance and enhance the use of eCOA e.g., maintaining data quality in decentralized trials or electronic submission to ethics committees.

In this webinar replay, the Clario eCOA Science team will share their interpretation of the new guidance and how the combination of these together with scientific input can help sponsors and biotechnology companies achieve a more patient-centric approach while maintaining data integrity in a flexible trial environment.