Professional Services, Upgrade and Migration Services for Oracle (EDC/SAE)

The Defense Health Agency's Office of the Principal Medical Executive Directorate (DHA OPMED) seeks professional services to support, upgrade, and provide technical expertise for the Oracle Electronic Data Capture (EDC) and Serious Adverse Event (SAE) systems. These systems are critical to facilitating and managing clinical trials, encompassing reporting capabilities, regulatory compliance, and FDA validation for the Department of Defense (DoD), DHA, and the military services.

The DHA OPMED eIT Project Management Office, based at Fort Detrick in Frederick, Maryland, oversees these Oracle Health Sciences Global Business Unit (HSGBU) products, including Inform Central Designer, Central Coding, Inform Adapter, CRF Submit, Go-To-Market (GTM), and Argus Safety Software. The contract scope includes technical support, system upgrades, configuration, training, mentoring, and sustaining operational readiness for both current and future iterations of these products. The selected provider must demonstrate expertise with Oracle Database Software, business processes, technology designs, and compliance with DoD and FDA requirements in the context of clinical data and adverse event management.

Additionally, the service provider should be able to manage product upgrades, align with evolving system requirements, perform effective configuration management, and ensure all related training materials and processes remain current with product name changes and updates. The objective is to maintain robust, compliant IT systems that enable DHA and the Services to advance medical research capabilities while meeting all regulatory guidelines.