Doug Shaw

Jan 5, 2024 | clinicalleader.com | Penelope Przekop |Doug Shaw |Karen Travers |Ed Drower

Why Sponsor Awareness Cannot Be "Day Zero" For SUSAR ReportingIn Part 1, we highlighted the FDA's focus on safety, not serving as a compliance safety net for sponsors through arbitrary rules on SUSAR reporting timelines. Part 2 delves into reader-raised justifications for using sponsor awareness as Day Zero for SUSAR reporting, exploring why these arguments fall short.

Dec 19, 2023 | clinicalleader.com | Doug Shaw |Karen Travers |Hannah Rose Yee |Ed Drower

By Doug Shaw, Karen Travers, Ed Drower, and Hannah Yee In a recent Speaker Series hosted by Halloran on "Operational Disruption: Assuring Clinical Data Integrity," our team delved into the complexities and critical factors involved in safeguarding data integrity, addressing both preventive and reactive measures.