Clinical Research Operations & Management Support (CROMS)   4

Background
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases has a requirement for the provision of clinical trials management support services.

Work Details
The contract is for Clinical Research Operations and Management Support (CROMS) for more than 200 active clinical trials at both domestic and foreign sites. The support functions include safety monitoring, safety oversight structures, clinical site monitoring and reporting, pre-study activities, medical writing services, maintenance of a website and centralized data system, data management and analytics, internal quality assurance and control plan, training programs for clinical site personnel, and the ability to expand staffing during any contract year if options to increase level-of-effort are exercised as directed by NIAID/DMID.

Period of Performance
The contract has a base period of one year with six one-year options to extend the contract term for a maximum period of performance of seven years. The period of performance begins on or about April 12, 2024.

Place of Performance
The place of performance is currently unknown.