Clinical Trial Management System for TB Clinical Research

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.

• NAICS54151
• PSCDA10

• Questions_Answers Worksheet.xlsx

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• AI Use Compliance and Risk Attch 5.pdf

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• Letter of Supply Template Attachment 3.docx

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• Attachment 1 SOW crosswalk.docx

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• VPAT Report- Attachment 6.docx

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• SOL-75D30126Q79181 DB.pdf

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• Pricing Schedule Attachment 2-.xlsx

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• RFP-CLINICAL TRIAL MANAGEMENT SYSTEM-FE.pdf

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• CTMS questions Attachment 4_.pdf

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• Liubov Kriel
  vyh1@cdc.gov17704482856
• Debra Baker
  xvv9@cdc.gov