SW-119695 - USA (Maryland) - Agentic AI and Document Intelligence Solution - Deadline September 24,2026

(1) Vendor needs to provide agentic AI and document intelligence solution • 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.• Automated ingestion of scanned PDFs, forms, emails, images, attachments, and electronic documents.• Classification of documents by Center–specific workflow, product type, and reporting pathway.• Adverse event terms, symptoms, outcomes, seriousness, and event narratives.• Dates, timelines, exposure details, dose, route, duration, lot numbers, manufacturer information, and product identifiers.• Automated flagging of missing, inconsistent, conflicting, or low–confidence data.• Mapping to Center–specific safety data models and controlled terminology.• API–based integration with FDA systems, case–processing platforms, data lakes, document repositories, and workflow tools.• Automated summarization of long adverse event narratives and supporting attachments.• Full audit trail recording every AI–proposed redaction, reviewer decision, exemption code applied, and final release determination.• Generation of redacted PDF and document versions with visible redaction markers, exemption codes, and reviewer audit annotations.