Core clinical engineering and protocols for ICH E2B(R3) Compliance.
Pharmaceutical manufacturers are legally obligated to review all reports of adverse events related to their products. For serious, unexpected adverse reactions, companies must transmit an E2B(R3) XML report to the FDA and EMA within 15 calendar days of receipt.
PharmacoPlatform automates the entire case intake workflow: optical character recognition parses paper MedWatch forms, clinical NLP extracts patient demographics and drug dosages, and rule engines validate that all mandatory ICH E2B(R3) data elements are present, eliminating manual data entry bottlenecks.