Opportunity
SAM #FDA-75F40126Q00384
FDA Sole Source Procurement of Think Trends Software Licenses for AI-Driven Case Processing
Buyer
FDA Office of the Associate General Counsel for Administrative Law
Posted
August 26, 2026
Respond By
September 09, 2026
Identifier
FDA-75F40126Q00384
NAICS
511210, 541519, 541511, 533110
The U.S. Food and Drug Administration (FDA) is announcing its intent to award a sole source contract for Think Trends Software Licenses. - Sole source procurement to ThinkTrends, LLC for Think Trends Software Licenses - Software will automate and improve manual case-processing, extraction accuracy, and regulatory review workflows - Supports Center-specific adverse event reporting requirements with AI agents, human-in-the-loop validation, auditability, and secure deployment - Contract is for a one-year period, firm fixed-price - No competitive proposals will be requested; procurement is under FAR 6.302-1 authority - ThinkTrends, LLC is the specified OEM/vendor - Opportunity is for software licenses only; no additional services specified - Intended for use within FDA Centers and Offices
Description
The FDA Centers and Offices requires Think Trends Software Licenses to reduce manual case-processing burden, improve extraction accuracy, accelerate regulatory review workflows, and support Center-specific adverse event reporting requirements through configurable AI agents, human-in-the-loop validation, auditability, and secure deployment within FDA-approved environments. The proposed source has the sole unique technical and other resources required for this acquisition. This will be a one-year period of performance.