DvSum Partners with FDA to Accelerate Drug Development
- DvSum has been selected to support the FDA's digital transformation initiative for the Center for Devices and Radiological Health.
- The partnership involves overseeing data management, quality, and governance as part of a $300 million agreement with Booz Allen Hamilton.
- This collaboration aims to enhance data integrity and operational excellence in the FDA's drug development processes.
DvSum has partnered with Booz Allen Hamilton and the FDA to enhance the digital transformation of the Center for Devices and Radiological Health (CDRH). This collaboration aims to implement a Data Intelligence Platform that will improve data management, quality, and governance. The initiative is part of a broader effort by the FDA to modernize its processes and ensure the integrity of data used in drug development and regulatory activities. The partnership follows Booz Allen Hamilton's selection by the FDA's Center for Drug Evaluation and Research (CDER) to develop an Informatics Platform under a significant $300 million Blanket Purchase Agreement. DvSum's role is crucial as it will oversee the data quality and governance aspects, ensuring that the FDA's data remains accurate and reliable throughout its lifecycle. As the FDA continues to adopt digital solutions, the importance of data integrity cannot be overstated. DvSum's platform will be deployed within the FDA's GovCloud AWS environment, allowing for enhanced data accessibility and reliability. This deployment is expected to facilitate better monitoring and management of the FDA's data landscape. John Hopke, Vice President of Business Development at DvSum, expressed pride in being selected for this critical role, emphasizing the company's commitment to supporting the FDA's mission. The partnership not only highlights DvSum's capabilities but also signifies a step forward in the FDA's ongoing efforts to improve operational excellence and data governance in drug development.