Clinical Trial Management System for TB Clinical Research

Key Dates
Due Date

-

Posted Date

-

Agency & Value
Agency

CDC OFFICE OF ACQUISITION SERVICES

Contract Value

Not provided

Codes & Classification
Solicitation Number

2026-Q-97423

NAICS

-

Classification Code

DA10

Additional Details
Set Aside

NONE

Place of Performance

Atlanta, Georgia, UNITED STATES

SourceSAM
The Centers for Disease Control and Prevention (CDC), through its Office of Acquisition Services, has issued a combined synopsis/solicitation for the procurement of a Clinical Trial Management System (CTMS) to support tuberculosis (TB) clinical research. This opportunity, identified by solicitation number 75D30126Q79181 and procurement identifier 2026-Q-97423, is being managed by the National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), specifically the Division of Tuberculosis Elimination (DTBE) Clinical Research Branch (CRB). The primary objective is to acquire a software-as-a-service (SaaS) CTMS solution that will enable the planning, management, and tracking of clinical trial documents throughout the entire lifecycle of TB clinical trials conducted by the TB Trials Consortium (TBTC). The scope of this procurement encompasses the provision of a commercial CTMS platform tailored to the needs of TB clinical research. The system must facilitate comprehensive document management, workflow tracking, and trial oversight, ensuring regulatory compliance and operational efficiency for multi-site clinical studies. The intended outcome is to streamline the management of clinical trial data and documentation, thereby enhancing the effectiveness and integrity of TB research initiatives. Key requirements for this acquisition include the delivery of a robust, secure, and user-friendly CTMS that supports the full spectrum of clinical trial activities—from study planning and initiation to data collection, monitoring, and closeout. The system should be capable of handling sensitive health data, supporting collaboration among geographically dispersed research teams, and integrating with existing CDC research infrastructure as needed. The expected deliverables are a fully functional SaaS CTMS, associated user training, technical support, and ongoing system maintenance for the duration of the contract. This solicitation is issued as a Request for Quote (RFQ) under the streamlined commercial item acquisition procedures of Federal Acquisition Regulation (FAR) Subpart 12.6 and FAR 5.203. It is an unrestricted, full and open competition, with no set-aside for small businesses. The applicable North American Industry Classification System (NAICS) code is 513210 (Software Publishers), with a small business size standard of $47.0 million. The Product Service Code (PSC) is DA10, which pertains to IT and Telecom – Business Application/Application Development Software as a Service. The place of performance for this contract is Atlanta, Georgia, United States. The contracting entity is the CDC Office of Acquisition Services, operating under the Department of Health and Human Services. Interested vendors should direct all inquiries to the primary contact, Debra Baker, at [email protected], referencing solicitation #2026-Q-97423 in the subject line. A secondary contact, Liubov Kriel, is also available at [email protected]. The solicitation was posted on April 8, 2026, and remains active, with responses due by August 14, 2026, at 18:08. All relevant solicitation documents and attachments are available via the official notice URL on SAM.gov: https://sam.gov/opp/2021ed1c024b4cd1a754c90cf3456d24/view. This procurement represents a significant opportunity for qualified vendors specializing in clinical trial management solutions, particularly those with experience in supporting large-scale, multi-site public health research. Contractors should ensure their proposed solutions align with the CDC’s requirements for security, scalability, and regulatory compliance, and be prepared to provide comprehensive support throughout the contract lifecycle.
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