CDEROne Data Lakehouse for Efficient AI and Data Governance

The CDEROne Data Lakehouse Platform was developed with Databricks by Deloitte and is transforming FDA/CDER's data management landscape. This platform unifies diverse data types—structured, unstructured, and semi-structured—and eliminates silos, optimizes processes, and overcomes challenges while seamlessly integrating with robust tools in a high-performance computing environment. Hosted securely on AWS's FISMA High Government Cloud, the CDEROne Platform enables collaborative AI development, empowers data scientists, and provides for a multi-tenant governance structure. Databricks in CDEROne has revolutionized FDA/CDER's review process through its advanced AI/ML capabilities. As a centralized data repository, Databricks manages metadata contents, stores information in a machine-readable format, and simplifies downstream data operations. This implementation has streamlined manual operations, improved response times, and enhanced the efficiency of the drug review and approval process.