ThinkTrends Software Support

The Food and Drug Administration's Center for Drug Evaluation and Research is soliciting an AI-based Optical Character Recognition (OCR) solution to support their Bioresearch Monitoring Evaluation Support Tools (BEST) platform. The contractor must develop software capable of extracting data tables from bioanalytical PDF reports with greater than 90% accuracy, enabling FDA reviewers to filter datasets, perform calculations, and conduct critical analyses as part of Remote Regulatory Assessment initiatives. The solution must integrate with the existing Study Data Platform and process files through both real-time API calls and batch processing capabilities. The contract will be evaluated using the Lowest Price Technically Acceptable (LPTA) method, considering technical features compliance, Section 508 standards adherence, and total price. Quotes must be submitted electronically by July 28, 2025, at 3:00 PM Washington DC Local Time, with the solicitation originally posted on July 22, 2025.

This procurement is designated as a Total Small Business set-aside under NAICS code 541519 (Other Computer Related Services), structured as a single Firm Fixed Price contract. The period of performance spans one year from September 29, 2025, to September 28, 2026, with work to be performed in Silver Spring, Maryland. No incumbent contractor or specific award value is mentioned in the solicitation materials. The solution will support the FDA's remote inspection capabilities that were expanded during the pandemic, allowing investigators to conduct oversight of FDA-regulated sponsor sites through virtual means including livestreaming, teleconferences, and screen sharing. The government has clarified that it will not reimburse any costs incurred in preparing bids and is not obligated to issue an award based on this solicitation.