dilluns, 25 de gener del 2016

Commonwealth Informatics inks data deal with FDA

Commonwealth InformaticsCommonwealth Informatics said today it inked a 2-year research collaboration agreement with the FDA to improve Commonwealth’s Clinical Data Analytics platform.

The CCDA is clinical data analytics platform designed to be used by healthcare and medical product researchers looking to analyze multiple data sources. The collaborative deal will allow Commonwealth to improve the software, the Waltham, Mass.-based company said, improving speed and quality of data reviews and enabling analysis of complex drug safety data.

“The Commonwealth team includes clinical and safety data experts who have developed several widely-used pharmacovigilance, clinical research, and healthcare data analysis systems. CCDA is a breakthrough technology that empowers scientific and clinical decision makers to rapidly absorb and explore multiple types of relevant data sources. I look forward to this unique opportunity to collaborate closely with the FDA to enhance CCDA to meet FDA’s evolving needs,” prez Geoffrey Gordon said in a press release.

Through the collaborative agreement, the FDA will provide expert scientific, clinical and statistical input to enhance the CCDA platform, which in turn will support FDA reviewers in “rapidly detecting and investigating safety signals during new drug application reviews and post-market pharmacovigilance activities,” the company said.

Generally, clinical data analysis is performed by by individuals, and data must be interacted with directly to generate final results. When coupled with complex data, extra reworkings and more time are added to the process.

The CCDA allows clincians and analysts to collaboratively work together across diverse data sources to allow for sophisticated data prep and analysis without traditional programming. The platform was developed in part through contacts sponsored by the Defense Health Program and the Army Pharmacovigilance Center, Commonwealth Informatics said.

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