ThinkTrends Advances AI-Powered OCR for Laboratory Device Logs and Bioanalytical Studies for the US FDA
Herndon, VA – October 1, 2024 – ThinkTrends, a leading provider of AI-driven solutions for regulated industries, today announced its continued partnership with the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), supporting the agency’s efforts to modernize regulatory review and remote inspection processes through advanced automation and artificial intelligence (AI).
Working under the Office of Computational Science (OCS) at FDA CDER, ThinkTrends has developed and deployed a powerful AI-based Optical Character Recognition (OCR) solution that integrates with key FDA platforms, including the Study Data Platform (SDP), Bioresearch Monitoring Evaluation Support Tools (BEST), and Remote Regulatory Assessment (RRA) systems. The solution is specifically designed to extract critical data from highly unstructured bioanalytical lab reports and medical device audit trails, transforming scanned documents into structured, actionable information for FDA reviewers.
Our partnership with the FDA is a powerful example of how AI can be applied to drug safety and regulatory challenges at scale. By automating the extraction of data from large, unstandardized documents, we’re reducing human workload. This is a real-world example of AI helping reviewers focus on higher-value analysis and support more timely and informed regulatory decisions. Jyotiska Biswas, CEO, ThinkTrends
ThinkTrends’ AI models achieved over 96% accuracy in data extraction and reduced processing times from 24 hours per report to just 10 seconds. The platform’s flexibility allows for both real-time and batch processing, giving FDA teams operational control and the ability to scale with future workload demands.
All extracted data is stored in a secure repository, ensuring accessibility for authorized reviewers. To augment transparency and oversight, ThinkTrends also deployed a comprehensive monitoring dashboard that provides real-time performance metrics, error reporting, confidence scoring, and automated notifications for both batch and on-demand processing. Hosted securely on GovCloud, the system is designed to adapt and scale as regulatory needs evolve, ensuring long-term value for FDA’s modernization initiatives.
About ThinkTrends
ThinkTrends is a pioneer in no-code AI and RPA solutions for healthcare, life sciences, and government agencies, empowering organizations to unlock the full potential of their data without writing a single line of code. Trusted by federal partners and industry leaders, ThinkTrends delivers secure, scalable AI that enhances decision-making, ensures compliance, and streamlines complex workflows.
For more information about ThinkTrends and its AI-powered regulatory automation solutions, visit www.thinktrends.co.
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