Your agents, live.
ROI in the first quarter.
30%Cut in IT costs
80%Of repetitive tasks automated
<6 weeksTo deploy — zero data leaves your environment
Pharmacovigilance Operations · HITL Medical Decisions · 21 CFR Part 11 Ready
Intake to ICSR in one agentic workflow. AI does the heavy lifting. Qualified humans make every medical call.
Main Description
The PV Case Processing Agent automates the full pharmacovigilance case lifecycle, from intake to ICSR submission. It handles data extraction, validation, coding, narrative drafting, and deadline tracking. Your PV Analysts, Medical Reviewers, and Supervisors keep every medical and regulatory decision.
How It Works
Monitors 8 intake channels: email, SAE forms, eCRFs, call centers, legal reports, and social media. Assigns a 7-day, 15-day, or periodic timeline on Day 0.
Extracts reporter, patient, drug, and event details with confidence scores on each field. Sends follow-up queries for missing data and escalates when no reply is received.
Searches by patient, event, drug, reporter, and onset date. Links duplicates to the original case, never deletes records, and prevents duplicate reporting.
Suggests MedDRA and WHO Drug Dictionary codes and drafts a 1 to 2 page case narrative for analyst confirmation before release.
Runs a 7-point quality check and routes the case to the Medical Reviewer with a tracked 2-day or 6-day deadline based on seriousness.
Medical Reviewer decides causality, expectedness, and seriousness. Agent flags SUSAR candidates and updates submission deadline tracking.
Assembles the ICSR in ICH E2B(R3) format. PV Supervisor approval is required before any submission is sent.
Pharma and biotech sponsors, CROs, PV service providers, and clinical trial safety teams.
ICH E2B(R3), ICH E6(R2), and 21 CFR Part 11.
Full audit trail, source-document retention, and encrypted patient data are built into the workflow.
