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AI in Case Processing and ICSR Automation

Case processing is the end-to-end lifecycle of an Individual Case Safety Report: intake and triage, validity assessment, data entry, MedDRA coding, narrative writing, medical review and regulatory submission. It is also where AI delivers the largest structural gain in pharmacovigilance - because most of that lifecycle is high-volume, well-bounded work that agents can run continuously under human supervision.

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AI in Pharmacovigilance

What Runs Autonomously

Supervised, Sampled, Audited.

Multi-channel intake

Reports arrive from every channel: healthcare professionals, patients, social media, literature, any B2C source. Agents normalise them into one workflow with one audit trail.

Case intake and triage

Every source, every format. Agents assess minimum validity criteria (identifiable
patient, reporter, suspect product, adverse event) and route cases by seriousness and timeline.

Duplicate detection

Continuous cross-source deduplication before cases enter the workflow. Not a periodic cleanup exercise.

MedDRA coding and narrative drafting

Standardised coding and clear, chronological narratives drafted by agents, quality-sampled by humans.

What a human always authorises

Some decisions never run unsupervised. The agent assembles the case, reasons over it, and presents a decision-ready package - its evidence and its uncertainty made explicit. A qualified human authorises; the agent cannot proceed without that signature:

Causality assessment sign-off
Seriousness and expectedness judgements
Expedited report submission

Medical judgement needs a human with accountability. We help you draw that line and document it so it holds up in an inspection.

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The Volume Problem, Solved Structurally

Costs fall because agents absorb the high-volume work that previously required additional headcount - the saving is structural, not rate arbitrage.

Quality rises because every case follows the same qualified process, AI captures all the details contained in the source document, every action lands in a single end-to-end audit trail, and exceptions are flagged by the system itself.

Not a sample. Every decision. Every action.

FAQ

The end-to-end management of Individual Case Safety Reports — from intake and validity assessment through coding, narrative writing and medical review to regulatory submission and archiving.

An identifiable patient, an identifiable reporter, a suspect medicinal product and a suspected adverse event.

Not compliantly. Intake, duplicate detection and data extraction automate well; causality, seriousness and expedited submission decisions require a qualified human's signature — by system configuration, not policy.

Published industry claims range up to 50% cycle-time reduction; the structural effect we design for is larger — agents absorb volume continuously, so human time concentrates on the decisions that carry risk.

Yes - the agentic layer operates with your existing systems and SOPs; no rip-and-replace required.

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