SAE Management

A Sponsor's Pharmacovigilance Team

SCiAN's SAEPRO system is a natural extension of EDCPRO and meets stringent requirements for collecting, validating and reporting of serious adverse events.  SciAn works with medical professionals in the study indication to review SAE reports and assess seriousness and expectedness with respect to industry reporting requirements.

  • Customize -Host - Manage Safety (SAE) Database
  • Collect, process and assess SAEs
  • Determine regulatory reporting requirements (seriousness and expectedness) of adverse drug reactions
  • Prepare reports for regulatory agencies (CIOMS I, MedWatch)
  • Disseminate reports to Sponsors and other parties
  • Develop and maintain integrated global safety databases
  • Evaluate and analyze Safety databases for safety signals
  • Update IND Annual reports, Investigator Brochures