Clinical Trial Management System for TB Clinical Research
Closed Solicitation Posted
- Solicitation number
- 2026-Q-97423
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 54151 Computer Systems Design and Related Services
- Place of performance
- Atlanta, Georgia 30333, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Centers for Disease Control and Prevention seeks a cloud-based Clinical Trial Management System (CTMS) software as a service to plan, manage, and track clinical trial documents for the TB Trials Consortium, with proposals due August 14, 2026 at 2:00 PM EDT and questions due August 7, 2026 at 2:00 PM EDT. This is a full and open competitive acquisition under FAR 12.6 streamlined procedures for commercial items.
Place of performance is Atlanta, Georgia. The system must be FDA 21 CFR Part 11 compliant and support 20 CDC user accounts, 22 trial site accounts across eight countries, and 50 electronic investigator site file portal users with role-based access, document versioning and audit history, and integration with CDC's existing electronic data capture system and Secure Access Management Services via SAML or OAuth. The contractor must obtain and maintain FedRAMP Low authorization throughout contract performance, including continuous vulnerability monitoring and annual third-party assessments. System configuration and implementation must occur within 15–50 days of award.
The base contract period runs September 1, 2026 through August 31, 2027, with two optional one-year extensions available. The contract will be awarded on a firm-fixed-price basis. NAICS codes are 513210 (Software Publishers), 541511, and 541512, with a small business size standard of $47.0 million. PSC is DA10 (IT and Telecom—Business Application/Application Development Software as a Service).
Offerors must submit three volumes: technical approach (15-page limit), past performance demonstrating similar clinical trial software implementations and FedRAMP experience (5-page limit), and pricing proposal with labor category rates and software subscription costs. Offerors using resellers must provide a letter of supply from the original software manufacturer. The government will conduct best-value evaluation without exchanges with competitors. Contracting Officer inquiries should be directed to Debra Baker at vxvv9@cdc.gov.
Notice text
The Center for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Division of Tuberculosis Elimination (DTBE) Clinical Research Branch (CRB) intends to award a purchase order to purchase a software as a service clinical trial management system (CTMS) to plan, manage, and track clinical trial documents throughout the lifespan of a TB clinical trial for the TB Trials Consortium (TBTC). This acquisition is unrestricted (Full and Open)
This competitive acquisition is conducted under the streamlined ordering procedures of Federal Acquisition Regulation (FAR) 12.6 and (FAR) 5.203.
(i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement contains the only solicitation; proposals are being requested and a written solicitation will not be issued later.
(ii) Solicitation number 75D30126Q79181 is issued as a Request for Quote (RFQ).
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-01.
(iv) This acquisition is Unrestricted (Full and Open Competition). The associated North American Industry Classification System (NAICS) code is 513210 (Software Publishers),541511 and the small business size standard is $47.0 Million.
Inquiries shall be sent to Debra Baker by email at vxvv9@cdc.gov and reference solicitation #2026-Q-97423 and title on the subject line.
Files
| File | Type | Posted |
|---|---|---|
| Questions_Answers Worksheet.xlsx | XLSX spreadsheet | |
| VPAT Report- Attachment 6.docx | DOCX document | |
| SOL-75D30126Q79181 DB.pdf | ||
| Letter of Supply Template Attachment 3.docx | DOCX document | |
| AI Use Compliance and Risk Attch 5.pdf | ||
| Attachment 1 SOW crosswalk.docx | DOCX document | |
| RFP-CLINICAL TRIAL MANAGEMENT SYSTEM-FE.pdf | ||
| CTMS questions Attachment 4_.pdf | ||
| Pricing Schedule Attachment 2-.xlsx | XLSX spreadsheet |
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