The Centers for Disease Control and Prevention has released a full and open solicitation for a commercial Clinical Trial Management System (CTMS) supporting the Division of Tuberculosis Elimination’s Clinical Research Branch and the Tuberculosis Trials Consortium (TBTC). The requirement combines a commercial cloud-based platform with implementation, system integration, FedRAMP security, technical support, and ongoing platform operations for CDC’s tuberculosis clinical research program.
CDC is conducting tuberculosis clinical research through the TB Trials Consortium, which includes 22 trial sites in eight countries. According to the Statement of Work, the program currently relies on paper documentation to manage regulatory records, monitoring activities, and clinical trial documentation required under FDA 21 CFR Part 11. CDC is acquiring a Clinical Trial Management System to manage trial documentation, monitoring activities, study startup, and document tracking throughout the life of each clinical trial.
The contractor will provide the CTMS platform, configure the system, conduct user acceptance testing, integrate the platform with CDC’s Electronic Data Capture system through application programming interfaces, provide onboarding and user training, maintain the application, and deliver ongoing technical support. The platform must include electronic Trial Master File functionality, document version control, electronic signatures, configurable dashboards, workflow management, role-based access, monitoring capabilities, and reporting across multiple studies and research sites. CDC also requires program staff to be able to perform system configuration changes without developer support.
The solicitation requires the contractor to obtain and maintain FedRAMP Low authorization through agency sponsorship, integrate with CDC Secure Access Management Services for user authentication, perform continuous security monitoring, complete recurring third-party security assessments, protect data in transit and at rest, and perform secure data transition and media sanitization at contract completion consistent with NIST SP 800-88. The Government intends to award a single contract with a 12-month base period and two 12-month option periods using a best-value tradeoff evaluating technical capability, security, past performance, and price.
Commercial CTMS providers, life sciences software companies, health IT firms, FedRAMP cloud providers, and systems integrators with experience implementing regulated SaaS platforms for federal health agencies or clinical research organizations should review this opportunity.
Read more here.
Solicitation Number: 2026-Q-97423
