Private by designAI That Catches Adverse Events Before They Become Crises
PharmacovigilanceAI reviews incoming AE reports, auto-codes to MedDRA, screens for safety signals via SMQ clustering, and routes critical events to your safety officer — with full ICH E2B(R3) audit trail.
The Pharmacovigilance Problem
Manual AE coding takes days
A single serious adverse event report requires 4–6 hours of manual MedDRA coding, narrative writing, and E2B submission preparation. At 50 reports/month, that's 200–300 hours.
SMQ signal detection is reactive
Drug safety teams discover pharmacovigilance signals in aggregate reports — weeks after individual cases accumulate. AI screens every case in real-time.
E2B submission errors cause rejection
Manual ICH E2B(R3) XML generation is error-prone. Rejected submissions require rework cycles that delay safety reporting to regulators.
How It Works
From raw AE report to EudraVigilance-ready submission in minutes.
AE Report Intake
Structured and unstructured sources — call transcripts, emails, forms.
MedDRA Auto-Coding
Verbatim term → PT/HLT/HLGT/SOC with confidence score.
SMQ Screening
Checks 100+ Standardised MedDRA Queries for safety signal clusters.
Causality Assessment
WHO-UMC scale assessment, automated narrative drafting.
E2B(R3) XML Export
Ready for EMA/FDA EudraVigilance submission.