Current Edition

Critical Considerations for Clinical Trial Safety Reporting Investments

Naturally, safety event reporting and pharmacovigilance (PV) should be subject to detailed regulatory scrutiny as evidenced by the Food and Drug Administration (FDA) overseeing the protection of human subjects and improving trial conduct by ensuring appropriate safety procedures are in place. It’s critical that the right information reaches the right constituents for reporting adverse events in a clinical trial. Tim Billington at Pharmasol defines the key aspects that impact clinical trial safety reporting processes, such as excessive reporting by sponsors and the need to automate and intelligently integrate siloed information to facilitate safety document distribution.