Clinical Research Operations Core
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is planning a Presolicitation for a Clinical Research Operations Core Indefinite Delivery/Indefinite Quantity (IDIQ) contract. This opportunity seeks to provide resources and services to implement clinical research in support of NIAID's mission, focusing on infectious and immune-mediated diseases. The Request for Proposal (RFP) is anticipated to be available on SAM.gov around February 27, 2026.
Purpose
The primary purpose is to enable NIAID to conduct a broad range of clinical research, including clinical trials, surveillance, natural history, and cohort studies. This research is crucial for addressing public health needs, such as emerging infectious diseases (e.g., SARS-CoV-2, Ebola, influenza), potential bioterrorism agents, and NIAID priority pathogens. The goal is to produce high-quality data supporting regulatory and policy decisions.
Scope of Work
The contractor will provide resources and services to implement clinical research, collaborating with existing NIAID contractors for monitoring, regulatory support, safety oversight, and data management. The IDIQ contract will support tasks across three key areas:
- Project Management and Protocol Development (Task Area A)
- Protocol Implementation and Clinical Operations (Task Area B)
- Research Laboratory Analysis (Task Area C)
All activities must comply with applicable U.S. federal regulations, international regulatory authorities, and DHHS, NIH, NIAID, and DMID policies for human subjects research.
Contract Details
- Type: Indefinite Delivery/Indefinite Quantity (IDIQ) contract.
- Award: NIAID anticipates awarding a single IDIQ contract based on best value to the U.S. government.
- Set-Aside: None specified (open competition).
- Place of Performance: Rockville, MD.
Response Information
- RFP Availability: Electronically on SAM.gov on/about February 27, 2026.
- Submission Method: Proposals must be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov/). Facsimile or e-mail submissions are not acceptable.
Contacts
- Primary: Cindy Hargett (cindy.hargett@nih.gov)
- Secondary: Ignacio Reyes, Contracting Officer (ignacio.reyes@nih.gov, 301-435-7574)