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SAMDAILY.US - ISSUE OF FEBRUARY 23, 2024 SAM #8123
SOLICITATION NOTICE

70 -- Trial Management System for TB Clinical Research

Notice Date
2/21/2024 5:51:22 AM
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
541512 — Computer Systems Design Services
 
Contracting Office
CDC OFFICE OF ACQUISITION SERVICES ATLANTA GA 30333 USA
 
ZIP Code
30333
 
Solicitation Number
5D301-24-Q-77531
 
Response Due
3/13/2024 9:30:00 AM
 
Archive Date
03/28/2024
 
Point of Contact
Courtney Cronin, Phone: 4044984088
 
E-Mail Address
jbp7@cdc.gov
(jbp7@cdc.gov)
 
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.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/5d77f3aa54fa4b98833e0b044b5531e7/view)
 
Place of Performance
Address: Atlanta, GA, USA
Country: USA
 
Record
SN06972777-F 20240223/240221230051 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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