NOI - External Institutional Review Board (IRB) Services for Multi-Site Studies
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 Heart, Lung, and Blood Institute (NHLBI) has issued a Notice of Intent (NOI) to award a sole source contract to Advarra, Inc. for External Institutional Review Board (IRB) Services for multi-site studies. This action ensures continuous IRB oversight for ongoing multi-site clinical research studies conducted under Investigational Device Exemption (IDE) and Investigational New Drug (IND) protocols, maintaining compliance with federal human subjects protection regulations. While not a competitive request, interested parties may submit capability statements.
Scope of Work
The required services include providing IRB oversight on an as-needed basis, encompassing initial and continuing review of multi-site study protocols, investigators, informed consent forms (ICFs), recruitment materials, amendments, and reportable events. The selected provider must serve as the IRB of record for ongoing multi-site FDA-regulated clinical studies, maintain continuity of oversight, support reliance agreements across multiple sites, and comply with 45 CFR 46 and 21 CFR 56. Secure handling of sensitive human subjects research information is also critical.
Contract Details
- Type: Sole Source (intended for Advarra, Inc.)
- Period of Performance: June 1, 2026 – May 31, 2027
- Place of Performance: Remotely via electronic communication.
- NAICS Code: 541990 – All Other Professional, Scientific, and Technical Services
- Set-Aside: Not set aside for small business.
Submission & Evaluation
This synopsis is not a request for competitive proposals. However, interested parties may submit a capability statement to demonstrate their ability to meet the Government's requirements. Submissions should include sufficient detail, pricing information, delivery timelines, business size status, and proof of active SAM registration. The Government reserves the right to determine whether to compete this proposed contract based on responses received.
Deadlines & Contact
- Response Due: May 5, 2026, at 9:00 am EDT.
- Submission Method: Electronically to Nicholas Capobianco (nicholas.capobianco@nih.gov).