Professional Services, Upgrade and Migration Services for Oracle (EDC/SAE)
Closed Pre-Solicitation Posted
- Solicitation number
- HT9427-26-RFI-702
- Agency
- Not on record
- Responses due
- Set-aside
- Competitive 8(a)
Opportunity facts
- NAICS code
- 541511 Custom Computer Programming Services
- PSC
- Not on record
- Place of performance
- Frederick, Maryland 21702, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency (DHA) Operational Medical Systems (OPMED) Enterprise Information Technology Project Management Office is seeking professional services for upgrade and migration support of Oracle Electronic Data Capture (EDC) and Serious Adverse Event (SAE) systems. The contract requires comprehensive technical support including training and mentoring, software upgrades, validation services, and technical remediation for Oracle Health Sciences Global Business Unit products such as Inform GTM, Central Designer, Central Coding, CRF Submit, Inform Adapter, and Argus Safety. Contractors must demonstrate established working relationships with Oracle and experience with FDA Title 21 CFR Part 11 compliance. The evaluation will focus on contractor capability to meet service level agreements including incident acknowledgment within seven days, critical issue resolution within one business day, and completion of routine requests within 30 calendar days. Responses to this Request for Information are due by 2:00 p.m. Eastern on February 3, 2026, submitted electronically to Jeanette Collins at jeanette.m.collins4.civ@health.mil, with submissions limited to three pages in Times New Roman 12-point font.
This procurement is set aside exclusively for qualified 8(a) small businesses under the Small Business Administration's 8(a) Business Development Program, with the anticipated contract type being Firm Fixed Price (FFP). The contract is categorized under NAICS code 541511 for Custom Computer Programming Services. The period of performance extends from March 28, 2026, through March 27, 2031, consisting of a 12-month base year plus four optional 12-month renewal periods, totaling five years of potential services. Required support hours are 8:00 a.m. to 4:30 p.m. Eastern, Monday through Friday, with 24/7/365 coverage mandated for Critical and High Priority Incidents. The scope includes up to four training classes annually, mentoring services not exceeding 200 hours per year, one major software upgrade (up to 1,500 hours) and one minor upgrade (up to 700 hours) per product annually, and monthly deliverables including status reports, project burn reports, and SLA metrics. No award value or budget range is disclosed in this pre-solicitation notice, and this RFI is information-gathering only with no contract award resulting from these responses.
Notice text
2 versions
Update #2 · Latest ·
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
12.0 Historical Task Order Number: W81XWH-20-C-0143
13. 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
Update #1 ·
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
Files
Similar open opportunities
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity