FDA Selects Commonwealth for Safety Support and Consulting Services

  WALTHAM, MA, - Commonwealth Informatics, a leading provider of cloud- based clinical and safety analytics products and services, today announced that it has been awarded a contract by the Food and Drug Administration to provide consulting services and technical assistance to the FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to support their use of the Empirica Signal software for quantitative safety signal detection and safety signal management.   Quantitative signal detection methods are used systematically by regulators and by large life science and pharmaceutical companies to identify emerging safety issues in therapeutic products. FDA researchers were among the early pioneers of quantitative signal detection methods and continue to expand the use of these methods to rapidly identify statistical associations between adverse events and drugs reported to the agency.   Under the contract, Commonwealth will provide weekly refreshes of the FDA’s signal detection environment, which includes use of the FDA Adverse Event Reporting System (FAERS) for drug products, the Vaccine Adverse Event Reporting System (VAERS) for biologic products, and the Empirica Signal software, and will support FDA’s use of the environment and interpretation of results.   “We are excited about the opportunity to support the FDA signal detection systems and processes,” said Geoff Gordon, President of Commonwealth Informatics. “Commonwealth staff were involved with the initial FDA signal detection software implementation done in the early 2000’s and we are looking forward to again working with safety evaluators from CDER and CBER.”   Commonwealth Informatics, a team of recognized experts in signal detection systems and methods, offers solutions ranging from assisting drug safety reviewers in making effective use of their existing signal detection systems to providing fully outsourced signal detection services.  

Commonwealth Informatics is a team of technologists and problem solvers with in-depth knowledge and experience working with spontaneous report and clinical datasets. Medical product developers, healthcare providers and government agencies use Commonwealth products and services to answer complex clinical and safety questions quickly and accurately. The Commonwealth team is a trusted collaborator with regulators, academia, life sciences companies and government agencies with a track record of creating innovative systems for the life sciences industry.