Commonwealth Informatics and the Food and Drug Administration have forged a two-year agreement to utilize the Commonwealth Clinical Data Analytics platform designed to help FDA assess drug safety data.
The company will work under the research collaboration agreement to help FDA reviewers detect and investigate safety signals when new drug applications are being tested, Commonwealth Informatics said Jan. 25.
“I look forward to this unique opportunity to collaborate closely with the FDA to enhance CCDA to meet FDA’s evolving needs,” said Geoffrey Gordon, Commonwealth Informatics president.
The agreement is signed as part of FDA’s 21st Century Review Initiative.