Electronic safety reporting in clinical trials: What sponsors need to know
For sponsors and CROs, it is crucial to understand the implications of the full enforcement of ICH E2B(R3) standards, especially as it impacts both pre- and post-authorization submissions.
Why ICH E2B(R3) still matters in 2026 – A conversation with Ducksang (David) Im
While E2B(R3) standard has existed for some time, global adoption has been gradual. What makes 2026 critical is that many regulatory authorities worldwide have now finalized mandatory transitions.
