A--Contract Research Organization for the National Institute on Alcohol Abuse and

SOL #: 75N94025R00008Pre-Solicitation

Overview

Buyer

Health And Human Services
National Institutes Of Health
NATIONAL INSTITUTES OF HEALTH NICHD
BETHESDA, MD, 20817, United States

Place of Performance

Place of performance not available

NAICS

Research and Development in the Physical (541715)

PSC

Health R&D Services; Health Care Services; Applied Research (AN12)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Timeline

1
Posted
Apr 7, 2026

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 on Alcohol Abuse and Alcoholism (NIAAA) plans to issue an RFP for a Clinical Research Organization (CRO) to provide clinical trial coordination and support services. This will be a 100% Total Small Business Set-Aside IDIQ contract. The RFP is anticipated on or about April 23, 2026.

Purpose & Scope

NIAAA seeks a CRO to support multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder (AUD). This is a follow-on requirement to contract 75N94019D00001. The CRO will be responsible for comprehensive support, including:

  • Clinical trial coordination and support.
  • Clinical site oversight and management.
  • Preparation of study documents.
  • Electronic data capture.
  • Good Clinical Practice (GCP) monitoring.
  • Acquisition, packaging, shipping, and coordination of study medication.
  • Logistical and meeting services.
  • Regulatory support.
  • Statistical and data analysis.
  • Final clinical study report preparation and manuscript submission. Clinical research sites will be established under separate NIAAA contracts.

Contract Details

  • Type: Indefinite Delivery/Indefinite Quantity (IDIQ) contract.
  • Ordering Period: Seven years, commencing November 15, 2026.
  • Task Orders: Individual task orders will be issued on a Cost Plus Fixed Fee basis. Approximately four to six CRO Clinical Study Support task orders are anticipated over the seven-year period.
  • Set-Aside: 100% Total Small Business Set-Aside (FAR 19.5).
  • NAICS: 541715, "Research and Development in the Physical, Engineering, and Life Sciences [except Nanotechnology and Biotechnology]" with a 1,000-employee size standard.
  • Limitations on Subcontracting: Small business prime contractors cannot pay more than 50% of the contract amount to subcontractors that are not similarly situated entities.

Key Dates & Information

  • Pre-Solicitation Published: April 7, 2026.
  • Anticipated RFP Release: On or about April 23, 2026.
  • Response Due: No responses are due at this time. This is an advance announcement.
  • Solicitation Availability: Electronically only via SAM.gov. Offerors are responsible for checking SAM.gov for amendments.

Contact Information

People

Points of Contact

WILLIAMS, JASON SPRIMARY
jason.williams2@nih.gov
+1 000 000 0000

Files

Files

No files attached to this opportunity

Versions

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Pre-Solicitation
Posted: Apr 7, 2026
A--Contract Research Organization for the National Institute on Alcohol Abuse and | GovScope