NIAID Clinical Trial Implementation Cooperative Agreement
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Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The National Institute of Allergy and Infectious Diseases (NIAID) is set to continue its support for clinical trial implementation through cooperative agreements aimed at investigator-initiated, milestone-driven, high-risk clinical trials that integrate both mechanistic studies and clinical research. This program underlines the importance of comprehensive support spanning the initiation, conduct, and completion of clinical trials. Key activities funded include training study personnel, recruiting and enrolling study subjects, data collection and management, quality control, investigational product costs, laboratory work, data analysis, study management, oversight, post-trial activities, regulatory compliance, and site monitoring. This effort is grounded in the authorities granted by Sections 301 and 405 of the Public Health Service Act and pertinent federal regulations. The cooperative agreements serve as a crucial mechanism to further NIAID’s mission by advancing innovative clinical research that can lead to better understanding and treatment of infectious diseases and allergies. Interested parties can obtain additional information or make inquiries through the designated contact, Dr. Cynthia de la Fuente at NIAID.
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Full Description
The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by continuing support for the NIAID Clinical Trial Implementation Cooperative Agreements. This program encourages cooperative agreement applications for implementation of investigator-initiated, milestone driven, high-risk clinical trials including mechanistic studies associated with these clinical trials. Due to this focus, the program encompasses both basic and clinical research. This program includes support for the conduct, completion, and analysis of the clinical trial. Additional activities supported are related to the conduct of the clinical trial including training of study personnel; enrollment and recruitment of study subjects; data collection, clinical data management and quality control; investigational product costs; laboratory work and data analyses; study management and oversight; post-trial activities; and regulatory activities and site monitoring. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
