Commonwealth Informatics, a provider of clinical and safety analytics products and services, signed a new contract to support the use of advanced drug safety review tools at the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The focus of the agreement is for Commonwealth to support the expansion of the use of the analytic suite of tools to help FDA manage their drug and product safety proactively and strategically in drug approval and post market surveillance.
The long-term objective of the project is to build on CDER’s and CBER’s present use of Oracle signal detection software and to expand its usage strategically. The expansion includes providing CDER safety reviewers with the ability to evaluate a wider spectrum of health information sources including spontaneous reports, electronic health records, clinical trials, product labeling, social media, biomedical citations, search logs, and chemical and biologic data. An increased capacity for supporting the modern regulatory review of medical products is an objective of FDA’s 21st Century regulatory review processes.
The near-term focus of the contract is to carry out an upgrade to the latest versions of the Empirica Suite tools the FDA is presently using and to provide enhanced support to the CDER and CBER user community. This support includes day-to-day on-site and remote training and assistance for end users, data curation and enhancement of data content and data feeds, support for related and add-on applications, and the provision of Subject Matter Expert (SME) services in the use of the tools.
“The Commonwealth team has both the technical expertise and domain knowledge needed to collaborate closely and effectively with the FDA on this project," said Geoffrey Gordon, Commonwealth Informatics President. “We look forward to working with FDA to help solve tactical challenges and deliver on strategic objectives that will improve the way safety data is analyzed.”