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DIA 2021 Global Annual Meeting


Solution Circle: The Burden of Safety Reporting on Sites - What Sponsors of Choice do Differently

Session Chair(s)

  WCG Clinical Services

WCG Clinical Services

  • 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

Steven Beales

  • Senior Vice President, Scientific and Regulatory Review
  • WIRB-Copernicus Group (WCG), United States