By Clinical Informatics News Staff

June 20, 2016 Commonwealth Informatics announced this morning 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.

In January, Commonwealth siggned a Research Collaboration Agreement with the FDA around their CCDA analytics tool.

FDA researchers were among the early pioneers of quantitative signal detection methods, and several members of the Commonwealth team were involved in the development of Empirica Signal software (now an Oracle product) years ago, explained Chan Russell, systems architect at Commonwealth Informatics.

Under the six-month, $146,000-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.

“[Adverse event] reports are flowing in all the time, and there’s a question of how often these signal scores are regenerated,” said Russell. “It used to be they were on a monthly basis… [which created] a time lag between when something might show up and when there starts to be an emerging signal. By increasing the frequency, you’re reducing the lag in the identification period.”  

In past years, the FDA’s new drug approvals have risen sharply. The contract signifies a scaling up of FDA’s use of Empirica Software for adverse event detection. “It’s something that has been in production and they’re looking to make broader use of it, and the work load is increasing,” Russell said.