The FDA Goes Live with ThinkTrends AI-Powered Document Processing Automation for Pre-Market Safety Reporting in FAERS II
Herndon, VA - March 21, 2025 - ThinkTrends, a leader in AI-driven automation for regulatory authorities and life sciences, announces the successful release of its AI-powered solution ‘Document AI’ for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). This milestone represents a significant advancement in modernizing the FDA’s Adverse Event Reporting System (FAERS) by streamlining the intake and processing of pre-market safety reports, ensuring compliance with ICH E2B (R2) standards.
ThinkTrends deployed an AI-powered data processing pipeline that integrates Optical Character Recognition (OCR), Robotic Process Automation (RPA), Natural Language Processing (NLP), and Large Language Models (LLMs) to transform high volumes of daily safety reports—across various unstructured formats—into structured, ICH E2B-compliant formats with a remarkable degree of reliability and accuracy for seamless ingestion into the FAERS case intake system.
A Trusted AI Partner for the FDA
ThinkTrends has been a trusted AI solutions provider for the FDA since 2018, delivering cutting-edge automation for a broad range of clinical, research, and inspection applications. Specializing in deploying AI-driven data processing, these solutions continue to eliminate tedious manual workflows, enhance accuracy, and accelerate regulatory activities.
We are thrilled to launch ThinkTrends Document AI pipeline for automated processing of pre-market safety reports for the FDA's Adverse Event Reporting System. Our AI-powered automation is reshaping how the FDA reviews and processes safety reports. What once required hours of manual data entry is now significantly reduced—freeing FDA reviewers to focus on higher-value risk assessments and critical safety decision-making for drugs and biologics. Jyotiska Biswas, CEO, ThinkTrends
About ThinkTrends
ThinkTrends is a pioneering AI company dedicated to developing cutting-edge AI and robotic process automation (RPA) solutions that transform the way businesses leverage data. Trusted by federal agencies and industry leaders, ThinkTrends delivers AI-driven tools that empower analysts to unlock the full potential of artificial intelligence—without writing a single line of code. Headquartered in Herndon, VA, ThinkTrends is built on a foundation of creative data scientists, engineers, and industry veterans committed to advancing data science, automation, and responsible AI innovation.
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