IND Drug Safety - SAE Management Solutions

Fully configured drug safety (SAE) databases using SCiAN's SAEPRO platform are available for IND stage (phases I - III) oncology clinical studies on a monthly subscription basis. The system is designed to collect, review, triage, adjudicate, and report serious adverse events (SAEs) for submission to regulatory agencies, IRBs/IECs. SAEPRO also supports integration of safety information into Investigator Brochures (IBs) and IND Safety Updates.

Key Features of SAEPRO: A Web-based Serious Adverse Event Reporting System

  • 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"
  • Proprietary "Guided Data Entry"™ system
  • Training manuals
  • User qualification module (on-line Quiz)
  • User registration and access control management module
  • Secure storage of associated source documents (emails, faxes, attachments/files)
  • Customizable workflow to match clients' business practices and SOPs
  • Auto email notification system
  • Regulatory submission tracking
  • Status reports
  • Excel database export
  • CIOMS-I and MedWATCH forms for reporting to agencies
  • Data import and export using CDISC ODM compliant XML format.