AEMS Think Trends Licenses (Brand Name)

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 other FDA-regulated products. Key capabilities include: Automated ingestion of scanned PDFs, forms, emails, images, attachments, and electronic documents. Classification of documents by Center-specific workflow, product type, and reporting pathway. Detection of new cases, follow-up cases, duplicate submissions, incomplete submissions, and supporting attachments. Intelligent routing to appropriate review queues, case-processing teams, or downstream systems. B. Agentic OCR and Intelligent Data Extraction Think Trends Software Agentic OCR shall combine optical character recognition, computer vision, natural language processing, large language models, and rule-based validation agents to extract key adverse event data elements from complex documents. The platform shall extract and structure critical case information, including: Reporter, patient, animal, subject, or consumer information. Product information, including drug, biologic, device, tobacco, or veterinary product details. Adverse event terms, symptoms, outcomes, seriousness, and event narratives. Dates, timelines, exposure details, dose, route, duration, lot numbers, manufacturer information, and product identifiers. Medical history, concomitant products, lab results, device problem codes, clinical narratives, and follow-up information. Center-specific data elements required for CVM-Drugs and CVM-Food, CDRH, CTP, CDER, CBER and HFP. C. Center-Specific Adverse Event Processing Agents The Contractor shall configure specialized AI agents within Think Trends Software to support unique regulatory and operational needs across FDA Centers. Each agent shall apply Center-specific data models, validation logic, terminology, business rules, and review workflows. Examples include: CVM Agent: Processes veterinary adverse event reports, animal species, breed, weight, product exposure, dosage, outcome, and veterinarian/reporter information. CDRH Agent: Processes device-related adverse events, device identifiers, manufacturer information, malfunction details, patient impact, and device problem descriptions. CTP Agent: Processes tobacco product adverse experiences, product use patterns, health effects, consumer narratives, and product category information. HFP Agent: Processes HFP-specific adverse event reporting requirements and associated workflows. CDER Agent: Process drug product adverse experiences, product use patterns, health effects, consumer narratives, and product category information. CBER Agent: Processes biologics product adverse experiences, product use patterns, health effects, consumer narratives, and product category information. D. Case Validation, Quality Control, and Human-in-the-Loop Review Think Trends Software shall incorporate validation agents to compare extracted data against business rules, required fields, confidence thresholds, terminology standards, and case-processing logic. Records that meet defined thresholds may proceed automatically, while exceptions shall be routed for human review. Key quality-control features include: Confidence scoring at field, document, and case levels.…