Platform Modules
Key Platform Modules
End-to-end PV workflow in a single integrated system
PV Intake
Multi-channel adverse event receipt — email, web form, EDC integration, literature monitoring feeds and spontaneous reporting.
Case Processing
Structured case entry, duplicate detection, MedDRA coding, seriousness assessment, and narrative authoring — with full audit trail.
AI Assistance
AI-assisted case narrative generation, automated MedDRA coding suggestions, and intelligent duplicate flagging to reduce processing time.
Analytics Dashboard
Real-time safety analytics: ICSR volume trends, time-to-report metrics, signal indicators, and MedDRA PT frequency heat maps.
E2B(R3) Submissions
Automated E2B(R3) XML generation with built-in validation and direct AS2/gateway transmission to EMA, FDA and MHRA.
Aggregate Reports
Automated line listings, summary tabulations and data extracts for PSUR, PBRER and DSUR report preparation.
Signal Detection
Statistical signal detection algorithms (PRR, ROR, IC) applied to cumulative safety data, with Signal Tracking Register built in.
DMS Integration
Document Management System for SOP storage, version control, training records and PvMF documentation — accessible to both teams.
