Frequently Asked Questions: 2023 EMA And FDA Guidance

By Bryan McDowell, M.Sc., M.B.A. – VP, eCOA Science and Consulting at Clario

As the eCOA environment undergoes changes, it's crucial to remain updated on regulatory directives and implement a strategic method for electronic data collection. Grasping the subtleties of these recommendations can significantly enhance the efficiency of clinical trials and the quality of collected data.

In a recent LinkedIn poll, Clario inquired its followers about their familiarity with the new eCOA-related regulatory guidance released this year. Out of over 140 responses, more than half revealed a level of awareness ranging from low to fairly low.

Following this poll, Clario hosted a webinar with Bryan McDowell, Clario's VP of eCOA Clinical Science and Consulting, to delve into critical questions posed by clinical trial teams. A recounting of the Q&A that took place during the virtual event can be accessed below. Responses have been refined for clarity.