Contract Research Organization for the National In

Quick Summary

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is soliciting proposals for Contract Research Organization (CRO) services to support its Medications Development Clinical Trials Network. This re-competition seeks comprehensive clinical trial coordination and support for multiple, multi-center pharmacotherapy trials focused on Alcohol Use Disorder (AUD). This is a 100% Small Business Set-Aside opportunity. Proposals are due June 10, 2026, by 4:30 PM Eastern Daylight Time.

Opportunity Overview

This acquisition is a re-competition for a follow-on contract to provide CRO clinical trial coordination and support services. The goal is to accelerate the search for new and more effective medications for AUD. The contract will be an Indefinite Delivery/Indefinite Quantity (IDIQ) vehicle with a seven-year ordering period, commencing around November 15, 2026. Individual task orders will be issued on a cost-plus-fixed-fee basis. It is anticipated that four to six CRO Clinical Study Support task orders will be issued during the IDIQ's ordering period, in addition to a Base IDIQ and Core and Study Development Support task order.

Scope of Work

The contractor will provide comprehensive CRO services for all aspects of multi-center clinical trials, including:

• Clinical trial coordination, site oversight, and management.
• Preparation of study documents, electronic data capture (EDC), and Good Clinical Practice (GCP) monitoring.
• Acquisition, packaging, shipping, and coordination of study medication.
• Logistical and meeting services, regulatory support, and statistical/data analysis.
• Final clinical study report preparation and submission, and manuscript preparation.
• Core and Study Development Support: Conducting literature reviews, assisting in new clinical protocol development (FDA/ICH guidelines), preparing regulatory affairs materials (e.g., pre-IND meeting packages, FDA submissions), and coordinating logistics for virtual meetings.
• Clinical Trials: Managing Phase II, Proof of Concept clinical trials (e.g., double-blind, placebo-controlled studies with 200 participants across 5 clinical sites over approximately 2 years and 2 months).

Contract Details

• Contract Type: Single-award Indefinite Delivery/Indefinite Quantity (IDIQ).
• Task Orders: Cost-plus-fixed-fee type.
• Period of Performance: Seven-year ordering period (anticipated November 15, 2026 - November 14, 2033), with a six-month extension option.
• Estimated Value: Guaranteed minimum of $5,000; maximum ceiling of $18,000,000.
• Set-Aside: 100% Small Business Set-Aside (NAICS 541715, 1,000 employees).
• Limitations on Subcontracting: The prime contractor cannot pay more than 50% of the contract performance amount to subcontractors that are not similarly situated entities.

Submission & Evaluation

• Proposal Due Date: June 10, 2026, by 4:30 PM Eastern Daylight Time.
• Questions Deadline: May 13, 2026.
• Submission Method: Electronically via the NIH electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov). Facsimile or email submissions are not accepted.
• Evaluation Factors: Technical, Cost/Price, and Past Performance (in order of importance).
• Required Submissions: Offerors must submit separate Excel budget proposals for the Base IDIQ (Core and Study Development Support) and a sample task order. Proposals must adhere to specific formatting and naming conventions.
• Compliance: Offerors must be registered in SAM, complete Section K representations/certifications, and provide a Supply Chain Risk Assessment Certification. All electronic reports and deliverables must comply with Revised Section 508 Standards.

Contact Information

• Primary Point of Contact: Jason S. Williams, jason.williams2@nih.gov, +1 301 443 3877.