PROFESSIONAL SERVICES, UPGRADE AND MIGRATION SERVICES FOR ORACLE (EDC/SAE)

The DHA OPMED is comprised of multiple subordinate commands with disparate organizational structures, mission areas, and internal processes. These entities provide a wide array of products and capabilities to enable the United States to provide, improve, and enhance the supply, protection, and sustainment of all the Armed Forces.

The DHA OPMED eIT PMO at Fort Detrick, located in Frederick, Maryland is responsible for providing medical research and regulatory Information Technology (IT) solutions to DHA and the Services in accordance with DoD and DHA policies and regulations. This primary mission includes several major activities:

• Actively maintain and manage requirements associated with eIT PMO IT Systems for DHA and the Services.
• Acquire, configure, and test IT capabilities to comply with approved requirements.
• Establish and maintain applicable Project Baselines. Ensure these are effectively managed with appropriate Acquisition Configuration Management (CM) Control and associated processes.
• Train the customer base, maintain, and sustain all operational IT systems and capabilities.

EDC became operationally ready in the Fall of 2012.  It houses all current and future clinical trials conducted by the DHA and the Services. The EDC product is comprised of several Oracle Health Sciences Global Business Unit (HSGBU) Software products which are: Inform (Overall System): Central Designer, Central Coding, Inform Adapter, Case Report Forms (CRF) Submit, and Go-To-Market (GTM).

SAE became operationally ready in 2010.  It provides a system for reporting adverse events associated with clinical trials conducted by the DHA and the Services. SAE is comprised of the Oracle HSGBU Argus Safety Software.

These comprise two (2) of five (5) Food and Drug Development (FDA) compliant major capabilities that the eIT PMO manages and maintains for the DHA and the Services. It is the eIT PMO’s intent to support product growth with this requirement. To learn more about the eIT PMO and SAE and EDC go to: https://www.dha.mil/Offices-and-Programs/OPMED/EIT

Objective and Purpose/Scope: Technical support services for Oracle in support of the Electronic Data Capture (EDC) and Serious Adverse Event (SAE) products following DoD and DHA regulations and eIT PMO policies. This requirement includes training, mentoring, technical support, and FDA validation support services for Oracles Inform GTM Central Designer, Central Coding, Inform Adapter, CRF Submit, and Oracle’s Argus Safety.

The scope of this requirement shall cover all products named or their equivalent Oracle Products, to account for name changes in training modules, product name changes, or product replacements. The eIT PMO requires the support service provider to understand Oracle Database Software, business processes and technology designs within the Oracle HSGBU Clinical Data Capture and Management and Adverse Event Reporting products.

North American Industry Classification System (NAICS) Code: 541511

12. RFI Attachments: The following documents are attached to the Sources Sought / RFI

            i.  Attachment 1 – DRAFT Performance Work Statement (PWS)

            ii. Attachment 2 - Company Information

           iii. B01-8(a) Sources Sought RFI HT9427-26-RFI-702-Final