Opportunity Overview
The U.S. Food and Drug Administration is soliciting AEMS Think Trends Licenses (Brand Name), FDA-SOL-75F40126Q00384, for an agentic AI and document-intelligence platform supporting adverse-event processing across FDA Centers.
Deadline
Quotes are due September 24, 2026 at 1:00 PM Eastern Daylight Time.
Scope
The requirement is for Think Trends software capable of ingesting, classifying, extracting, validating, routing, and transforming structured, semi-structured, and unstructured adverse-event documents, including scanned PDFs, forms, narratives, attachments, medical records, product complaints, laboratory reports, and case correspondence.
Required capabilities include agentic OCR, Center-specific adverse-event processing, human-in-the-loop quality control, confidence scoring and source traceability, data standardization and regulatory outputs, workflow automation and triage, duplicate and follow-up detection, reviewer-ready case summaries, secure FDA-aligned deployment, and AI-enabled redaction supporting FOIA review.
Competition and Classification
This is a brand-name requirement and the current notice lists no set-aside. NAICS is 541519, Other Computer Related Services, and PSC is DA10, IT and Telecom Business Application/Application Development Software as a Service.
Funding / Contract Value
No fixed maximum contract value is stated in the public notice.
Qualification Guidance
Potential respondents should review the brand-name RFQ and confirm licensing, deployment, adverse-event document intelligence, Center-specific configuration, integration, security, auditability, human review, FOIA redaction, and all other current technical and quotation requirements.