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# FDA Inks Collaboration Agreement on Drug Safety Data
- URL: https://www.fdaweb.com/fda-inks-collaboration-agreement-on-drug-safety-data/
- Published: 2016-01-25T12:00:00.000Z
- Updated: 2026-09-15T02:30:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134542

> FDA and Commonwealth Informatics have signed a two-year research collaboration agreement (RCA) to enhance the [Commonwealth Clinical Data Analytics](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.commoninf.com%2Fproducts%2Fccda%2F&esheet=51265351&newsitemid=20160125005835&lan=en-US&anchor=Commonwealth+Clinical+Data+Analytics%E2%84%A2&index=2&md5=47c43d9221c15298b6506f92fec4e54d&ref=fdaweb.com) (CCDA) platform for analyzing drug safety data. The platform is used by healthcare and medical product researchers to rapidly access, transform, explore and analyze multiple data sources. Under the agreement, the collaboration is intended to improve the software to “provide an advanced analysis capability which can help improve the speed and quality of data reviews, as well as enable critical analysis of complex drug safety data,” Commonwealth says. CCDA was developed in part through contracts sponsored by the Defense Health Program and the Army Pharmacovigilance Center.  
>  
> “CCDA can dramatically improve the clinical data analysis process by enabling clinicians and analysts to work together more collaboratively and seamlessly to find the right answers to complex questions,” the organization says. “It has an intuitive graphical user interface that allows users to work with diverse data sources via a simple, reproducible, step-by-step visual process, and this enables sophisticated data preparation and analysis without traditional programming.”  
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> 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,” Commonwealth says. “CCDA can improve the speed, quality, and transparency of analyzing complex drug safety data to support regulatory decision-making.”