Aggregate Safety Reports

 

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

 

1. Periodic post-marketing safety reports:

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

2. Periodic clinical trials related safety reports:

  • ASR
  • Semi-SUSAR
  • DSUR

3. Ad hoc safety reports

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

4. Other reports

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

 

G2 Strengths

  • US Based
  • 24/7 coverage
  • Safety expertise
  • Cost effective
  • Teamwork
  • Compliance-focused
  • Quality-driven
  • Timely turn-around
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