SAM #2026-Q-97423

CDC Seeks SaaS Clinical Trial Management System for TB Research

The Centers for Disease Control and Prevention (CDC) Division of Tuberculosis Elimination is seeking a Software as a Service (SaaS) Clinical Trial Management System (CTMS) to support TB clinical research. - Government Buyer: - Centers for Disease Control and Prevention (CDC) - Division of Tuberculosis Elimination, Clinical Research Branch - Products/Services Requested: - SaaS Clinical Trial Management System (CTMS) for planning, managing, and tracking TB clinical trial documents - System configuration and implementation, including: - 20 CDC user accounts - 22 trial site accounts - 50 eISF portal users - Technical support and system maintenance - Integration with CDC's Electronic Data Capture (EDC) system via API - Security authorization and ongoing FedRAMP Low-risk compliance, including 3PAO security assessments and vulnerability monitoring - Optional expanded electronic Trial Master File (eTMF) document storage (measured in GB/month) - IT transition and contract closeout services, including secure data delivery and media sanitization per NIST SP 800-88 - Period of Performance: - Three years total: base year plus two 12-month option years - Unique/Notable Requirements: - Compliance with FDA 21 CFR Part 11 for electronic records - FedRAMP Low-risk authorization and continuous security monitoring - Integration with existing CDC systems - Secure offboarding and data handling at contract closeout - No specific OEMs or vendors are named; procurement is open to all qualified providers of commercial CTMS solutions.

Description

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.

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