June 01, 2006
FDA’s ECG Warehouse Architects recognize Cardiocore’s Innovative Application of ECG Technologies
Bethesda, MD – Cardiocore announced today that it has achieved Mortara Certified Partner status. As a Mortara Certified Partner, Cardiocore has demonstrated the capability to provide ECG data in accordance with the HL7 V3 annotated ECG standard. Certification confirms that ECG data processed by Cardiocore will be fully compliant when submitted for regulatory review.
"Cardiocore is at the forefront of technology advancements for centralized cardiac safety testing," noted Cardiocore’s CEO,
Jennifer Cotteleer . "Our long standing collaboration with Mortara provides several key advantages. In this era of rapid change, we provide our customers early access to the newest ECG technologies, and we maintain optimum methods for continuous output of perfectly formatted XML files for entry in the FDA’s ECG warehouse."
Justin Mortara, Ph.D. commented, “Cardiocore has, in many ways, led the industry in adoption of new technologies. In 1996, they pioneered the use of Mortara’s 12-lead Holter for data intensive protocols. In a 2005 Thorough QT trial, they were the first to use Mortara’s High Fidelity Holter system. Also in 2005, Cardiocore was the first core lab to use Mortara’s electrocardiograph bar-coding system to minimize demography queries in a Thorough QT trial. Expert implementation of new technologies has helped to position Cardiocore as a growth leader in cardiac safety services, and we look forward to ongoing collaboration in the years ahead.”
The E-Scribe ECG Warehouse, developed in cooperation with the FDA, provides tools for annotated ECG review, scoring and warehousing. Annotated ECG datasets supporting new drug applications to FDA will be uploaded by sponsors and central laboratories which are able to generate HL7 compliant data into the E-Scribe ECG Warehouse to facilitate regulatory review using the toolset provided by Mortara.
Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 13 years. Services include centralized electrocardiographic (ECG) analysis, Holter monitoring, statistical analysis and consulting services such as protocol design. The company is experienced in both design and implementation of Thorough QT Trials as well as cardiac safety and efficacy testing in Phases I, II and III clinical trials. These services are supported by the company’s CardioCorrect® system featuring the HolterGateway™ and the CardioPortal™. Cardicore’s US headquarters is located in Bethesda, Maryland, and its European subsidiary, Cardiocore Limited, is located in London,
About Mortara Instrument
Milwaukee, WI , Mortara Instrument, Inc. is distinguished in the field of non-invasive cardiology for innovations that are the core of the company’s complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company’s website is www.mortara.com.