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.