Vendor / CRO Management (OBX-319)

Document ID: PM-006
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): Program management

Vendor / CRO Management — OBX-319

The outsourcing and vendor-oversight approach for the OBX-319 program: the CRO and specialty-vendor scope, selection and qualification, oversight and performance metrics, and the sponsor's retained-oversight responsibilities under ICH E6(R3).