SAE SOLUTION

Software for IND Drug Safety Databases

The SAEPro module was specifically developed for IND stage (phase I – III) clinical studies to collect, review, triage, adjudicate and report serious adverse events (SAEs) for submission to regulatory agencies, IRBs and IECs and for integration of all safety information into Investigative Brochures (IBs) and IND safety updates.

 

  • Continuous compliance with FDA safety reporting requirements
  • CIOMS-I and MedWATCH forms for agency reporting
  • Auto email notification
  • Secure source document storage (emails, faxes, attachments and files)
  • Complete help system
  • Regulatory submission tracking
  • Status reporting
  • Data import and export using CDISK ODM compliant formats

"SAEPro can stand alone or integrate seamlessly with EDCPro supporting a cost effective clinical safety program."

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