FY24 ThinkTrends Software Support

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. The operating environments of ThinkTrends have already been deployed across two distinct environments: pre-production and production. In the pre-production environment, there are two instances. One of them is GPU instance, used for running machine learning tasks.

The other instance is for proxy and front facing services. Production environments is set up similarly to pre-production environments with two instances. ThinkTrends has also been deployed to establish a connection with OCS Data Central even though this connection is not being used by any application as of now. The Contractor shall perform project management activities to ensure control, management, monitoring, and notification mechanisms to meet the requirements of this procurement. Review the attached RFQ document for the full description of the requirement.