Aggregate Safety Reports

Our safety team excels in helping our clients with aggregate safety reports.

Periodic post-marketing safety reports

  • PSUR (6 months, annual or 3-year)
  • Summary Bridging Report
  • Addendum
  • PADER (annual or quarter reports)
  • PBRER

Periodic clinical trials related safety reports

  • ASR
  • Semi-SUSAR
  • DSUR

Ad hoc safety reports

  • Clinical overview/summary for labeling update
  • Safety expert reports for assessment of safety queries

Other reports

  • Medical impact analysis (MIA) reports
  • Safety summary
  • Customized line listings and summary tabulations for aggregate data