EXA12
— Satisfy a regulator —
Pharmacovigilance
Adverse-event reporting under MHRA Yellow Card / FDA FAERS / EudraVigilance using the ICH E2B(R3) message format — Polymonial seals the clinical detail so the safety signal reaches regulators without identifying the patient.
The problem to solve
Post-market drug safety depends on adverse-event reports flowing from hospitals, prescribers, and patients to manufacturers and regulators — into the MHRA Yellow Card scheme, FDA FAERS, EudraVigilance, and WHO VigiBase. The standard ICH E2B(R3) message format carries identifying clinical detail through every node of the reporting chain. Patients hesitate to report; hospitals strip detail before forwarding (losing signal); regulators receive a degraded picture of the real safety profile. Risk visibility falls precisely because the existing pipeline can't separate the safety signal from the identifiable patient.
The solution it enables
Polymonial seals the clinical detail at the reporter. Schema-bound proofs satisfy each regulator's safety-signal requirements — drug, dose, MedDRA reaction class, severity grade, demographic stratum — without exposing identifying detail to intermediate processors. The same E2B(R3) envelope flows to MHRA / FDA / EMA; the schema controls what each authority unseals. Regulators gain a full epidemiological picture; patients stay unidentified.
What it looks like
A pharmaceutical regulator runs a Yellow Card / FAERS surveillance scheme for a newly-approved oncology drug. Hospitals submit ICH E2B(R3) reports each week, with the clinical-detail fields sealed. The regulator unseals only the schema-permitted fields of each report (drug, dose, reaction class, severity), and its own signal-detection team identifies a previously-unseen interaction with a common antihistamine. Reporting hospitals, the manufacturer's safety team, and the regional intermediary in the routing chain see only the schema-permitted slice of each report. The signal that protects future patients comes through; the identifiable detail does not.
“Yellow Card reports that travel through every regulator without identifying the patient who reported them. Safety surveillance regains the signal it has been losing.”
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