Real-World Application for Innovation and Development

The U.S. Food and Drug Administration (FDA) is issuing this source sought notice as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify viable industry parties capable of supporting FDA’s Real-World Application for Innovation and Development (RAPID), enhancement of the current AWS platform, development of new applications prototypes and Proof of Concepts.

The mission of CDER’s Office of Computational Science (OCS) is to modernize the Center’s regulatory review process and enable reviewers to spend less time dealing with complex data and more time applying their expertise to information through the use of integrated tools, services, and training. OCS’ efforts to accomplish this mission involve developing technology and analytics to support regulatory review work.

RAPID was developed as a means to implement a cloud-based and on-premises environment to develop and continuously improve the applications and databases needed to meet the innovation and analytical needs of FDA users.

The RAPID platform is capable of supporting a variety of cloud and other operations including, supporting individual regulatory research, ingest, evaluate, and validate new analytic tools and methodologies, support new methods of multi data base curation, characterization and integration for transdisciplinary analysis of complex and big data, and a range of artificial intelligence tools and use cases for FDA needs.

RAPID is a sandbox that promotes the development of innovative analytic tools, supports data science research, and the evaluation of cutting-edge technologies. The RAPID System in its current form uses Artificial Intelligence (AI) and cloud-based compute facilities to develop innovative analytical solutions that support regulatory decision making and scientific analysis.

Refer to the National Academies of Sciences “Convergence”, https://www.nae.edu/113283.aspx, report to get an understanding of what ”transdisciplinary FDA scientific need” must include.