AEMS Think Trends Licenses (Brand Name)

The FDA is seeking a firm‑fixed‑price award to provide Think Trends™ AI‑driven document‑intelligence software (licensing) for adverse event reporting across multiple FDA centers (CVM, CDRH, CTP, CDER, CBER, HFP). The solution must ingest, classify, OCR, extract, validate, triage, and redacted FOIA‑compliant adverse‑event documents (PDFs, forms, images, handwritten notes, etc.), support center‑specific data models, generate structured outputs (XML/JSON/CSV), and integrate via APIs with FDA systems. The contract includes a reinstatement period (12/15/2025‑09/29/2026) and a base‑year license period (09/30/2026‑09/29/2027). Delivery includes full platform configuration, center‑specific templates, integration testing, documentation, and training. • Provide AI‑agent‑based intake, classification, and routing of all adverse‑event submissions. • Perform agentic OCR and data extraction for drug, biologic, device, veterinary, and tobacco reports. • Implement center‑specific processing agents and validation rules. • Offer human‑in‑the‑loop review, confidence scoring, and audit trails. • Deliver FOIA‑compliant automated redaction of PII/PHI and confidential data. • Supply API‑based integration, export formats, and secure deployment in FDA‑approved cloud. • Include training, user guides, and post‑deployment support for a 12‑month period.