FDA ECG and Holter Warehouse Uploads

As a standard service, Cardiocore generates FDA HL7 XML files for every ECG. Cardiocore is Mortara Certified and well experienced in uploading these regulatory compliant digital files to the FDA’s ECG Warehouse. All of Cardiocore’s ECG Warehouse uploads on behalf of sponsors have been error-free with no upload or acceptance delays. These uploads include Thorough QT trial data and data from other cardiac safety studies including both digitally-acquired and ECGs digitized from paper.

Cardiocore is also the first core lab to submit data to the FDA’s Telemetric and Holter ECG Warehouse (THEW). Managed by the FDA and the University of Rochester Medical Center, the THEW provides access to terabytes of clinical trial Holter data for advanced research in cardiac safety testing technologies.