Trial Master File (TMFPRO)

SCiAN's SAEPRO platform has been developed for IND stage (phases I - III) clinical studies and offered on a monthly subscription basis to collect, review, triage, adjudicate, and report serious adverse events (SAEs) for submission to regulatory agencies, IRBs/IECs, and integration of safety information into Investigator Brochures (IBs) and IND Safety Updates.

Key Features of SAEPRO: A Web-based Intuitive, user-friendly interface

  • Compliant with FDA's new safety reporting requirements for IND studies (29-Sep-2010)
  • Comprehensive Help System with "Guided Data Management"