Global RBM requires interoperable architectures across EDC, IRT, eCOA, labs, imaging, EHR, and safety systems, but inconsistent CDISC/HL7 FHIR adoption and proprietary APIs impede near–real-time ...

37 practitioners. 5 pharma companies. One shared conviction: legacy computerized system validation no longer serves the industry it was built to protect The validation framework that protected ...