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Solution Circle: The Burden of Safety Reporting on Sites - What Sponsors of Choice do Differently
Session Chair(s)
WCG
United States
Safety reporting requirements place heavy burden on sites. Sponsors struggle to keep up with changing global regulations and end up overdistributing, sending duplicate or unnecessary reports. A review of 9 years of safety reports found 86% of safety letters received by sites were uninformative or unnecessary, and over 50% did not meet FDA expectedness and causality criteria. In this session, we discuss the changes implemented by a sponsor to become more favored in safety reporting by sites.
Speaker(s)
Steven Beales
WIRB-Copernicus Group (WCG), United States
Senior Vice President, Scientific and Regulatory Review
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