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

Form / Attachment / Pricing Sheet

This document is an attachment titled "Company Information" and serves as a template for bidders to provide essential details about their company. It is intended to gather information necessary for the government's review and potential pre-award survey.

• Company Name
• Company Address
• Point of Contact
• Phone Number
• E-mail Address
• Tax Identification Number (TIN)
• CAGE Code
• UEI Number
• North American Industry Classification System (NAICS) Code
• Company Web Page
• Company Location(s)
• Small Business Status
• SAM Registration Status
• Other Socio-Economic Classifications (e.g., 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service-Disabled Veteran-Owned)
• 8(a) Program Graduation Date (if applicable)
• Current Indirect Rate Agreement or Forward Pricing Rate Agreement (yes/no)
• Acceptable Cost Accounting System status (DFARS 252.242-7006 or SF 1408 pre-award survey)
• Federal Supply Schedule (GS Contract Holder) status and contract number (if applicable)

Bidders must complete and submit this form accurately to provide the government with the required company and business information. This information is crucial for determining eligibility, assessing capabilities, and potentially for accounting system compliance checks as part of the evaluation or award process.

Sources Sought / Request for Information (RFI)

This RFI is issued by the Defense Health Agency (DHA) Operational Medical Systems (OPMED) eIT Project Management Office (eIT PMO) to gain market knowledge regarding capabilities for providing technical support services for Oracle's Electronic Data Capture (EDC) and Serious Adverse Event (SAE) products. This is not a solicitation, and no contract will be awarded based on this RFI. The government may use the information gathered to inform future solicitations.

The requirement includes technical support, training, mentoring, and FDA validation support services for Oracle's Inform GTM Central Designer, Central Coding, Inform Adapter, CRF Submit, and Oracle's Argus Safety products. The scope covers all named or equivalent Oracle Products, including potential name changes or replacements.

• RFI Number: HT9427-26-RFI-702

• Issuing Office: Defense Health Agency Contracting Activity (DHACA)

• Issue Date: January 20, 2026

• Agency: Defense Health Agency (DHA)

• Location: Fort Detrick, Frederick, MD

• Contract Type: Firm Fixed Price (FFP) (Anticipated for future solicitation)

• Response Due Date: February 3, 2026, 2:00 PM Eastern Time.

• Submission Method: Via email to jeanette.m.collins4.civ@health.mil.

• Email Subject: "HT9427-26-RFI-702-Professional Services, Upgrade and Migration Services for Oracle (EDC/SAE)"

• Response Format: Limited to three (3) pages, Arial 12-point font, single-spaced, 8.5x11 inch paper with 1-inch margins. Submissions must be in Microsoft Word or searchable Adobe PDF format.

• Outline: Responses should include Title, Organization, Responding technical and administrative points of contact, and Topic area.

• Evaluation: Responses will be used to determine the respondent's ability to perform the scope of work. No evaluation letters or results will be issued.

• Responses are appreciated from ALL qualified capable 8(a) small businesses ONLY.

• Attachment 1: DRAFT Performance Work Statement (PWS)

• Attachment 2: Company Information

• Respondents are solely responsible for all expenses associated with responding.

• No phone calls will be accepted or returned.

• Proprietary information must be marked as such.

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide technical support services for Oracle's Electronic Data Capture (EDC) and Serious Adverse Event (SAE) products, including training, mentoring, technical support, and FDA validation support.

• Support for Oracle's Inform GTM, Central Designer, Central Coding, CRF Submit, Inform Adapter, and Argus Safety software.

• Services include training, mentoring, technical support, and FDA validation.

• The scope covers all named products or their equivalent Oracle Products.

• The contractor must provide monthly status reports, project burn reports, and ad-hoc reports.

• Service Level Requirements (SLRs) include defined response and resolution targets for incidents and service requests based on severity (Critical, High, Medium, Low).

• Quality Assurance Surveillance Plan (QASP) defines performance requirements, standards, and quality criteria.

• Anticipated period of performance: 12-month base year plus four 12-month option periods, totaling a potential five-year contract from March 28, 2026, through March 27, 2031.

• Support services are to be provided during government duty hours, with 24x7x365 coverage for critical and high-priority incidents.

• Contractor must be an Oracle Partner with demonstrated subject matter expertise and a working relationship with Oracle.

• Personnel must be skilled to address SAS-related service requests.

• Contractor must comply with FDA Title 21 CFR Part 11 regulations.

• Security requirements include background checks, adherence to installation access procedures, and potential compliance with FPCON changes.

• A Non-Disclosure Agreement (NDA) is required for all assigned staff.

• Contractor manpower reporting is required via a specific Army data collection site.