Safety Surveillance Systems
Averion utilizes the industry standard ARISgTM Safety System for comprehensive Adverse Event tracking and reporting. Our Medical Affairs department records all adverse events and tracks all associated workflow of the adverse events through ARISgTM. The system can be easily be customized to each clinical trial’s business needs. ARISgTM allows secure and restricted access to the safety data by the Sponsor or project team with a comprehensive audit trail facility and generattion of regulatory, safety and management reports for analysis.
ARISgTM collects, tracks, analyzes and reports adverse event data generated by Averion Pharmacovigilance personnel.
Averion has used ARISgTM for reporting to regulatory authorities, and has deployed the ARISgTM system across our global locations.
Safety Surveillance System Features:
- Comprehensive AE tracking and reporting system managed by Averion Pharmacovigilance Personnel for collecting, analysis and reporting
- Collect record details related to adverse events caused by drugs, biologics, medical devices, or vaccines
- Track all aspects of adverse events through the workflow cycle using the approval concept
- Implement restricted security access to safety data by sponsor and by project
- Utilize comprehensive audit trail facilities
- Generate various regulatory, management, and safety reports for analysis
ARISg is a trademark of ArisGlobal® LLC.