Notice ID: 75F40123Q00550
Description
The Food and Drug Administration (FDA) is a science-based regulatory agency critically important to the stability of the nation’s public health and health care systems. FDA protects and promotes the health and safety of all Americans by enhancing the availability of safe medical products and foods and promoting innovation that addresses unmet medical and public health needs. FDA’s decisions must be based on the available scientific data, tools, and methods in order to ensure products, under FDA’s jurisdiction, meet high quality standards for consumers, while fostering and advancing innovation in the products it regulates.
Objectives As part of the BEST platform, the contractor shall provide an AI-based OCR (Optical Character Recognition) function that provides a PDF extraction solution. The solution shall be able to extract data tables from bioanalytical reports in a PDF format at greater than 90% accuracy level to allow for reviewers to access data in a format which is amenable to filtering specific data sets, performing calculations, and other analyses that are critical to their processes. The government should be able to leverage this solution for other projects that are part of the Remote Regulatory Assessment (RRA) initiatives. RRA allows FDA investigators to perform FDA-regulated sponsor site inspections remotely. It includes voluntary interactive evaluations (such as remote livestreaming video of operations, teleconferences and screen sharing) in addition to requests to review records and other information under existing statutory or regulatory authority. Throughout the pandemic, the FDA has used these tools, domestically and abroad, to help the agency conduct oversight, mitigate risk, and meet critical public health needs. The BEST platform described above is an example of RRA.
Task 1 – ThinkTrends Software Support for OCR PDF Extraction
Thinktrends is a data mining and AI workflow automation platform that allows users to create custom AI models that allow detection of objects from images with minimal coding. This technology may significantly improve the accuracy of OCR text and table extraction. ThinkTrends OCR API and ThinkTrends PDF AI are the ThinkTrends products to facilitate PDF extraction, conversion, verification, and automation from bioanalytical reports…
Task 2- Project Management
The Contractor shall provide all artifacts developed to support this contract to the COR. These artifacts shall become the property of the Government.
Details of deliverables for the project management task are shown in section 2 of this document. The Contractor shall provide Transition in and Transition Out services to ensure a smooth transition from one period of performance to another, and from contractor’s organization to a new organization if there is a change in contracting vendors. Services include but not limited to knowledge transfer, mentoring, etc. to ensure efficient continuation of the whole Study Data Platform program.
