SafetyDrugs is able to produce the following pharmacovigilance reports:

  • line listing
  • summary tabulation
  • Pregnancy form
  • PSUR
  • DSUR
  • SMQ
  • MedWatch both for drugs and for devices
  • MIR
  • Audit trail
  • Quality check report
  • Cover report
  • and other dozen of customizable listings for inspective/audit purposes.

All reports are exportable in Excel format.

In addition, the Business Intelligence module is available with which it is possible to perform even more detailed analysis such as comparison between time intervals, quantitative analysis, KPI analysis, parameterizable line listings, signal detection and standard MedDRA queries.