Automated Adverse Event Case Processing

# Automated Adverse Event Case Processing

Every pharmaceutical company is legally required to collect, assess, and report adverse events (AEs) associated with its marketed products. An Individual Case Safety Report (ICSR) captures each event — from initial intake through assessment, coding, narrative writing, and regulatory submission. For large pharma companies, this means processing tens of thousands of ICSRs annually.

The ICSR Processing Pipeline

Each ICSR moves through a defined workflow: 1. Intake — Receiving the report from healthcare professionals, patients, literature, or spontaneous reporting systems 2. Triage — Determining if the report is valid (identifiable patient, identifiable reporter, suspect product, adverse event) 3. Data entry — Capturing demographics, medical history, event details, suspect and concomitant medications 4. MedDRA coding — Assigning standardized terms from the Medical Dictionary for Regulatory Activities 5. Causality assessment — Evaluating the likelihood that the product caused the event 6. Narrative writing — Drafting a clinical narrative that summarizes the case 7. Quality review — Senior safety professional reviews the complete case 8. Submission — Transmitting to relevant health authorities within regulatory timelines (15 days for serious, 90 days for non-serious)

Where AI Fits