INTENT TO SOLE SOURCE AEMS Think Trends Licenses (Brand Name)

The FDA’s Centers and Offices are seeking a one‑year license for Think Trends software, an AI‑enabled platform that automates case‑processing, improves data extraction accuracy, and supports adverse event reporting through configurable agents, human‑in‑the‑loop validation, auditability, and secure deployment within FDA‑approved environments. Because ThinkTrends, LLC is the only source with the required technical capabilities, the FDA is issuing a sole‑source, firm‑fixed‑price contract. Interested parties may submit a capability statement by the September 9, 2026 deadline; otherwise the award will proceed to ThinkTrends. • One‑year SaaS license for AI‑driven case‑processing software. • Sole‑source award under FAR 6.302‑1; no competition. • Intended to reduce manual workload, increase extraction accuracy, and accelerate regulatory review. • Submission of capability statements only; no formal proposal required. • Contract type: firm‑fixed‑price, software‑as‑a‑service.