Core clinical engineering and protocols for Statistical Signal Detection.
A pharmaceutical safety database contains tens of thousands of adverse event reports. Finding a genuine rare adverse reaction—such as drug-induced autoimmune hepatitis—requires sophisticated statistical screening to separate true drug signals from co-morbid background noise.
PharmacoPlatform computes continuous disproportionality metrics (PRR, ROR, and BCPNN Information Components) across rolling product cohorts. When a drug-event combination crosses pre-defined statistical thresholds, the platform automatically flags an emerging safety signal and routes it to pharmacovigilance physicians for causality review.