What's included

What goes into expedited reporting

  • SUSAR identification and causality assessment against a documented methodology, not an ad hoc call per case
  • 7- and 15-day expedited timelines met using reporting workflows built and tested before go-live
  • Health authority and IRB submission tracked against each jurisdiction's clock
  • Expedited reports reconciled with the case series feeding DSUR/PSUR preparation, so nothing is reported twice or missed
  • A traceable submission record for every SUSAR, ready for sponsor or agency review

Never a scramble

Reporting workflows are built and tested during start-up, so the clock starts on a process that's already proven, not one assembled after the first case.

Reconciled, not duplicated

Every SUSAR is cross-checked against the case series feeding DSUR/PSUR preparation, so nothing is reported twice or missed.

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