Pharmacovigilance Surveillance

World-class drug safety signal management for first-world PV teams. Protocol → FAERS/E2B ingest → screening → BCPNN IC025 signal detection → subgroup stratification → structured causality scoring → assessment → regulatory output (CIOMS I, E2B(R3), PSUR/PBRER) — every step audit-grade, with HIPAA/GDPR/PIPEDA-aware redaction and cross-border transfer gates.

Signal detection & alerting

Proper Bayesian BCPNN IC025 (Bate et al. 1998) plus PRR / ROR with Haldane-corrected 95% CI — the EudraVigilance / WHO-VigiBase convention. Subgroup stratification by gender, age band, and region catches effect modifiers the pooled analysis hides. Alert thresholds, quiet periods, and audit records help teams triage material signal changes without treating heuristics as confirmed causality.