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,...