Commonwealth Informatics Signs Research Collaboration Agreement

Commonwealth to work with FDA to Enhance Clinical Data Analytics Platform for use in Safety Reviews

WALTHAM, MA, January 25th, 2016 -- Commonwealth Informatics, a leading global provider of cloud-based clinical and safety analytics products and services, today announced that it signed a two-year Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA). The focus of the agreement is to enhance the Commonwealth Clinical Data Analytics™ (CCDA) platform for analyzing drug safety data. CCDA is a flexible clinical data analytics platform used by healthcare and medical product researchers to rapidly access, transform, explore and analyze multiple data sources. It is anticipated that the enhanced CCDA software resulting from this research collaboration will 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.

Typically, clinical data analysis is carried out by several individuals with specialized knowledge and skills across multiple functional areas. Medical officers and safety reviewers need the ability to easily interact directly with the data and inspect and verify the intermediate analytical steps taken to generate final results. However, because of the complexity of the data, time and rework are often added to the process.

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. It has an intuitive graphical user interface that allows users to work with diverse data sources via a simple, reproducible, step-bystep visual process, and this enables sophisticated data preparation and analysis without traditional programming. CCDA was developed in part through contracts sponsored by the Defense Health Program and the Army Pharmacovigilance Center.

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. CCDA can improve the speed, quality, and transparency of analyzing complex drug safety data to support regulatory decision-making. The project will contribute to the FDA’s 21st Century Review Initiative.

“The Commonwealth team includes clinical and safety data experts who have developed several widely-used pharmacovigilance, clinical research, and healthcare data analysis systems,” said Geoffrey Gordon, Commonwealth Informatics President. “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.”

About Commonwealth Commonwealth Informatics is a leader in global cloud-based clinical and safety analytics products and services. Committed to innovation and transforming the process of analyzing clinical and safety data, the Commonwealth team has more than 30 years of experience successfully collaborating with academia, regulators and sponsors to deliver improved clinical and safety informatics products to medical product reviewers. For more information, visit www.commoninf.com.