Software for IND Drug Safety (SAEPRO) Databases
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 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
- Tracking regulatory submissions
- Status reports
- Excel database export
- CIOMS-I and MedWATCH forms for reporting to agencies
- Data import and export using CDISC ODM compliant XML
format.