October 1, 2010 – The U.S. Food and Drug Adminstration (FDA) Center for Drug Evaluation and Research (CDER) has awarded two contracts to support the agency’s review of cardiac safety data. Both contracts were given to Mortara Instrument.
The first award is a multi-year contract for continued maintenance of the FDA ECG Warehouse, and the second will expand the warehouse to incorporate continuous 12-lead ECG recordings.
The FDA has been using Mortara’s toolset to review ECG studies since 2006. To facilitate the review process, it incorporates the Veritas ECG algorithms, which analyze and quantitatively evaluate the submitted ECG data. Today it contains more than 4 million ECGs from more than 420 studies.
Under the maintenance contract, Mortara will continue to support FDA personnel and provide ongoing basic enhancements to the ECG Warehouse.
Data submitted from cardiac safety studies are often extracted from continuous ECG recordings done with 12-lead Holter monitors or 12-lead telemetry at protocol-specified times. Under the contract, Mortara will provide the FDA with the means to review the full underlying data set as well as the extracted ECGs. The expanded warehouse tools will include Web-based upload, navigation of continuous data, arrhythmia identification and waveform morphology comparison.
The intent is to support review of continuous recordings that are typically the underlying data source for the discrete ECGs that are currently being submitted. This will be the first step in positioning the FDA to request the upload of continuous recordings as part of the cardiac safety regulatory review process.
For more information: www.mortara.com