AEMS Think Trends Licenses (Brand Name)

Scope

The Contractor shall provide Think Trends Software as an Agentic AI and Document Intelligence solution capable of processing structured, semi-structured, and unstructured adverse event documents, including scanned PDFs, handwritten or machine-generated forms, narratives, attachments, medical records, product complaints, lab reports, follow-up submissions, and case correspondence. The solution shall support end-to-end adverse event document processing through the following capabilities: A. Agentic Document Intake and Classification Think Trends Software AI agents shall automatically receive, classify, and route adverse event documents by submission type, FDA Center, product category, source, urgency, and case-processing requirements. The intake agent shall identify whether a document relates to drugs, biologics, devices, veterinary products, tobacco products, combination products, or…

Documents, amendments and submission instructions are on the agency's own posting.