Commonwealth Informatics Will Work with FDA on Safety Reviews
Applied Clinical Trials
FDA will provide expert scientific, clinical and statistical input to guide the further enhancement of CCDA to support FDA reviewers in rapidly detecting and investigating safety signals during new drug application (NDA) reviews and post-market pharmacovigilance activities.
Commonwealth Informatics, a global provider of cloud-based clinical and safety analytics products and services, announced that it signed a two-year Research Collaboration Agreement (RCA) with the FDA. The focus of the agreement is to enhance the Commonwealth Clinical Data Analytics™ (CCDA) platform for analyzing drug safety data.
Under the RCA, FDA will provide expert scientific, clinical and statistical input to guide the further enhancement of CCDA to support FDA reviewers in rapidly detecting and investigating safety signals during new drug application (NDA) reviews and post-market pharmacovigilance activities. The project will contribute to the FDA’s 21st Century Review Initiative.
