Clinical Trial Management System for TB Clinical Research

The Centers for Disease Control and Prevention’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention is seeking a Software as a Service clinical trial management system to support the Tuberculosis Trials Consortium by enabling end-to-end planning, management, and tracking of clinical trial documentation for tuberculosis research. This acquisition is conducted as a full and open competition under FAR 12.6 and 5.203 using a Request for Quote with solicitation number 2026-Q-97423, and it follows the Federal Acquisition Circular 2026-01. The procurement targets a web-based, cloud-hosted CTMS platform that requires no software installation on CDC devices and must integrate seamlessly with CDC Secure Access Management Services via SAML or OAuth. The system must fully comply with 21 CFR Part 11 for electronic records and signatures, support role-based access for up to 20 CDC staff, 22 individual trial site accounts, and 50 eISF portal users, and provide a fully auditable electronic trial master file with version control, metadata tracking, and recording of CDC and IRB approval dates. The vendor must ensure FedRAMP Low-risk authorization with continuous monitoring, maintain FIPS 140-2 encryption for data at rest and in transit, and provide full accessibility compliance through a completed HHS Section 508 Conformance Checklist or VPAT-based ACR. Security, accessibility, and data handling standards include mandatory adherence to NIST SP 800-88 for data sanitization upon contract closure and strict prohibitions on unauthorized AI use, including restrictions on government data ingestion for training or tuning purposes without explicit approval. Proposals must be submitted in three volumes: a 15-page technical approach demonstrating system architecture, compliance, and configuration timelines; a 5-page past performance section with three relevant references showcasing clinical trial software experience, FedRAMP maintenance, and offboarding protocols; and a no-page-limit price proposal that separates software license costs from labor rates using dynamic, formula-driven pricing sheets without static values. The contract will be awarded as a Firm-Fixed-Price plus Labor-Hour arrangement, evaluated through a trade-off process prioritizing technical superiority, information security capability, past performance, and price reasonableness. Performance begins September 1, 2026, with a 12-month base period and two optional 12-month extensions, totaling up to three years. Key deliverables must be completed within 5