# Trial Management System for TB Clinical Research Canonical: https://abierto.us/opportunities/5d30124q77531 - Solicitation number: 5D301-24-Q-77531 - Notice type: Combined synopsis and solicitation - Status: Closed. Deadline was March 13, 2024 at 12:30 PM EDT - Department: Department of Health and Human Services - Agency: Centers for Disease Control and Prevention - Contracting office: CDC Office of Acquisition Services (75D301) - NAICS: 541512 Computer Systems Design Services - Product or service code: 7H20 Hardware, software, and other equipment needed for local database instances, distributed platform, application and system integration resources enabling cross application development, communications and information sharing. Includes Mainframe database and middleware products and tools. - Place of performance: Atlanta, Georgia - City: Atlanta. https://abierto.us/cities/atlanta-ga-1304000 - First posted: February 21, 2024 - Last posted: February 21, 2024 - SAM.gov: https://sam.gov/workspace/contract/opp/5d77f3aa54fa4b98833e0b044b5531e7/view ## Description NOTICE OF INTENT TO ISSUE AN ORDER. This is not a request for competitive proposals/quotes. The Centers for Disease Control and Prevention (CDC) hereby announces its intent to issue a sole source order to OpenClinca LLC, at 163 Highland Ave, 1173, Needham MA, 02494 for Trial Management System for TB Clinical Research. In 1997 CDC and the investigators from these sites decided to reorganize their activities, creating the TB Trials Consortium, or TBTC. TBTC is based in the Clinical Research Branch (CRB) of CDC’s Division of Tuberculosis Elimination (DTBE). The CRB includes medical officers, epidemiologists, health scientists, clinical research specialists, laboratorians, data analysts, data managers, statisticians, and contract specialists. Formal by-laws for TBTC were adopted in 1998, establishing a central Steering Committee, made up of one representative from each site and one from CDC, as well as several executive committees: Core Science Group (CSG); Implementation and Quality Committee (IQC); Publications and Presentations committee (P&P); and Advocacy and External Relations (AER). The purpose of the Steering Committee was to develop a long-term comprehensive scientific agenda for the TBTC. An Executive Affairs Group (EAG), composed of committee chairs and CRB leadership, was to serve as the executive arm of the Steering Committee, and was responsible for day-to-day decision-making. Current funding has awarded contracts to a new group of TBTC trial sites for the next 10-year cycle, from September 2020 to September 2030. There are also trial sites funded via an interagency agreement with the Veteran’s Administration. While TBTC data have historically been managed using a custom-built Trial Management system, the functionality of the current system has significant limitations. Modern systems are specifically built for clinical trial data use and are highly adaptable, have more features, and are less expensive than the current system in use. It is the intent of the DTBE that TBTC continue its efforts to conduct therapeutic, diagnostic, and preventive research in support of the CDC goal of TB elimination. An improved system will provide TBTC clinical trials with a faster, more comprehensive, and responsive system for data intake, trial monitoring, and drug management at less cost, enhancing the TB control program of the United States and the mission of domestic TB elimination. This contract will be for two years. ## Publications - February 21, 2024: Combined synopsis and solicitation, due March 13, 2024 at 12:30 PM EDT. Notice 5d77f3aa54fa4b98833e0b044b5531e7. https://sam.gov/workspace/contract/opp/5d77f3aa54fa4b98833e0b044b5531e7/view ## Points of contact - Courtney Cronin, jbp7@cdc.gov, 4044984088 --- Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/5d30124q77531.