Adverse events.Signal detection.Peace of mind.
A web-based pharmacovigilance platform that streamlines safety data gathering during clinical trials and post-market surveillance — centralised AE reporting, signal detection and risk management.
Centralised AE reporting, signal detection and risk management — purpose-designed for compliant, auditable pharmacovigilance workflows across any device.
Seven modules.
One ecosystem.
Real-Time AE Capture
Adverse events, complaints and inquiries captured from site through to sponsor in real time.
Integrated Medical Coding
MedDRA, WHO-DD, ICD-10 and SNOMED dictionaries integrated for AE, drug and medical history coding — keeping safety data submission-ready.
Customisable Dashboards
Live metrics, trend tracking and configurable alerts for specific events, users or regions.
Reporting Wizard
Dynamic report creation with predefined filters. Export to PDF or CSV in SDTM, standard or custom formats.
Automated Letter Generation
Map system data to configured templates. Scheduled or manual transmission on admin-configured events.
Full Audit Trail
Detailed audit trail on every event reported — complete transparency for regulatory audits and post-market surveillance.
Role-Based Workflows
Medical monitoring with role-based review. Reduced under-reporting via automated reminders and rules.
Built deep.
Configured fast.
- ICH E2B R3 · Individual Case Safety Reports
- CIOMS reporting
- Signal detection analytics
- Auto-submission · VigiBase integration