Intelligent ICSR Processing & Signal Detection
Business Challenge: PV operations handle tens of thousands of Individual Case Safety Reports (ICSRs) annually — manual intake, MedDRA/WHODrug coding, and narrative writing average $70–$200 per case, while signal detection across literature, RWD and social data remains reactive. AI-Enabled Solution: NLP + LLMs automate ICSR intake from any channel, auto-code adverse events, draft seriousness assessments and narratives, and continuously mine multi-source data for early safety signals — all integrated with the safety database for full auditability.
PATIENTS WE PROTECT — MONITORED ACROSS REAL-WORLD CHANNELS
CYCLIC AI-DRIVEN PROCESS FLOW
| AI CAPABILITIES |
| ■ NLP intake from email, PDFs, voice transcripts, literature & call-center logs |
| ■ Auto-coding to MedDRA & WHODrug with confidence scoring |
| ■ LLM-drafted ICSR narratives, seriousness & expectedness assessment |
| ■ Multi-source signal detection (spontaneous, literature, RWD, social) |
| ■ Aggregate report (PSUR/PBRER/DSUR) draft automation |
| BENEFITS & KPIs | |
| Case processing time | −55% |
| Auto-coding accuracy | 92% |
| Earlier signal detection | +30% |
| PV operations cost | −25% |
| Late-submission compliance risk | −40% |