Clinical Research Operations Core

Introduction 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. NIAID has a requirement provide the resources and services needed to implement clinical research in support of its mission. Description Through multiple grant- and contract-funded research programs, NIAID supports a broad range of clinical research, including single-center and multi-center Phase 0-4 clinical trials of therapeutics and vaccines, including new vaccine formulations, schedules, and modes of delivery; surveillance or natural history, and cohort studies for pathogens of interest; and evaluation of novel diagnostics. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., SARS-CoV-2, Ebola, influenza, etc.), potential agents of bioterrorism, and NIAID priority pathogens and may include finding additional uses for already approved therapies for selected infectious diseases via clinical trials and clinical studies. These clinical research activities are crucial from a public health perspective because they help guide policy decisions regarding product use and/or facilitate development and evaluation of therapeutic candidates critical to advancing product development and, therefore, aid in public health preparedness. The purpose of this pending solicitation is to provide the resources and services needed to implement clinical research in support of NIAID’s mission. This will allow NIAID to respond to public health needs including public health emergencies and produce high quality data supporting regulatory and policy decisions. NIAID anticipates awarding an Indefinite Delivery Indefinite Quantity (IDIQ)-type contract to an offeror that meets the overall qualifications for Base efforts and individual Task Areas to support the full range of activities for conducting clinical trials using qualified clinical staff with expertise in carrying out all aspects of interventional clinical trials. The Contractor shall collaborate with companies under contract to NIAID that provide clinical site monitoring, regulatory support, safety oversight, and data management and analysis. The new IDIQ contract awards will support tasks, with concomitant bioanalysis when applicable, in the following areas: Project Management and Protocol Development (Task Area A) Protocol Implementation and Clinical Operations (Task Area B) Research Laboratory Analysis (Task Area C) NIAID anticipates awarding a single Indefinite Delivery/Indefinite Quantity (IDIQ) type contract to Contractors that meet the overall qualifications for Parent Contract and individual Task Areas and will be based on best value to the U.S. government. All projects carried out under the IDIQ contract(s) must be conducted in a manner consistent with all applicable U.S. federal regulations or international regulatory authorities, and the DHHS, NIH, NIAID, and DMID policies and guidelines for the conduct and oversight of research involving human subjects. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about February 27, 2026, and may be accessed through SAM.gov. This notice does not commit the Government to award a contract or Task Order. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.nih.gov/ and then click on “How to Submit.”