October 17, 2005
Certification demonstrates readiness to support sponsor submission of annotated ECG data in accordance with HL7 standard.
Issaquah, WA (October 17, 2005)––Spacelabs Medical Data announced today that it has achieved Mortara Certified Partner status. Certification under this program ensures that Spacelabs Medical Data’s ECG measurement tools and processes generate XML files for its clients that adhere to the Health Level 7 (HL7) annotated waveform standard required for U.S. Food and Drug Administration (FDA) application review. As part of the submission process, annotated ECG datasets are to be loaded directly into the E-Scribe ECG Warehouse to facilitate regulatory review. The E-Scribe ECG Warehouse, developed by Mortara Instrument in collaboration with the FDA, requires all annotated datasets to meet the HL7 standard in order to be successfully imported into the warehouse.
In June 2004, the FDA entered into a Cooperative Research and Development Agreement (CRADA) with Mortara to develop and implement the digital data warehouse to collect, store and archive ECG data from clinical trials, which FDA reviewers will use to assess the cardiac safety of new drugs. The E-Scribe ECG Warehouse includes dataset import and format validation capabilities, web-based query and review of data, scoring systems for rank ordering ECG records and studies of interest and advanced tools for research-oriented analysis and display of ECG data.
As a Mortara Certified Partner, Spacelabs Medical Data will provide its clients with the benefits of adherence to the final HL7 standard and smooth importation of annotated ECGs into the E-Scribe ECG Warehouse. “We’re in the business of helping our sponsors bring their new drugs to market in the most efficient and economical way possible,” said Marc Hagan, general manager of Spacelabs Medical Data. “As one of the first Mortara Certified Partners––and as a cardiac safety core lab with two decades of global experience––Spacelabs Medical Data will work closely with Mortara to lead in ECG technology adoption and provide enhanced services to sponsors worldwide,” added Hagan.
Randy Spaulding, Vice President of Clinical Research at Mortara commented, “Spacelabs Medical Data has proven itself able to meet the rigors of the HL7 standard annotated ECG requirements and as such we are pleased to add Spacelabs Medical Data to our list of Mortara Certified Partners.” Continued Spaulding, “Spacelabs Medical Data, alongside the other early Certified Partners, is leading in its demonstration of technology readiness for HL7 annotated digital ECG submissions to the E-Scribe ECG Warehouse. “
About Spacelabs Medical Data
Spacelabs Medical Data (www.spacelabsmedicaldata.com
) is a leading global provider of centralized ECG and ambulatory blood pressure monitoring (ABPM) research services for pharmaceutical companies, biotechnology firms, academia, CROs and device manufacturers. Founded in 1985, Spacelabs Medical Data offers expertise across the full spectrum of ECG services, including 12-lead ECG, Holter monitoring (12-lead and 3-channel) and ABPM for Phase 1 through 4 clinical trials. Spacelabs Medical Data is a division of Spacelabs Medical, Inc., an OSI Systems Company, www.osi-systems.com
About Mortara Instrument
Based in 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
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