This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on February 21, 2024. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Trial Management System for TB Clinical Research

Closed

5D301-24-Q-77531Federal

Submission Closed03/13/2024, 04:30:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541512

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Inc Federal Prison Industries

POSTED

about 18 hours ago

DEADLINE

in 6 days

General Info

Agency

Department Of Health And Human Services → CDC Office Of Acquisition Services

NAICS

541512 - Computer Systems Design Services

Place of Performance

Atlanta, GA, USA

Set-Aside

NONE

Documents

OpenClinica Trial Management System SOW

7 pages · sow

High

Notice of Intent Sole Source - OpenClinica Trial Management System

4 pages · presolicitation

Low

Sole Source Justification - OpenClinica Clinical Trial Monitoring System

justification-and-authorization

Low

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

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Timeline

PhaseClosed

PostedFeb 21

Combined Synopsis

Response DeadlineMar 13

Deadline has passed

Submission Closed

03/13/2024, 04:30:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → CDC Office Of Acquisition Services

Contacts1 person available

OfficeATLANTA, GA, 30333, USA

Organization / AgencyDepartment Of Health And Human Services → CDC Office Of Acquisition Services

Office AddressATLANTA, GA, 30333, USA

Contacts

Courtney Cronin

contact@example.gov

+1 (555) 000-0000

Full 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.