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Collaboration Includes Development and Validation of Automatic ECG Analysis Tools for use in Clinical Trials
Milwaukee, WI - March 9, 2009 —Spaulding Clinical Research, a next generation Clinical Research Unit designed from the ground up for Cardiac Safety studies, announced today a strategic agreement with Mortara Instrument. As part of the agreement, both companies shall collaborate on the design, implementation and verification of new ECG acquisition, analysis and report generating technologies for clinical testing of new drugs.
Major elements of this cooperation include:
- Full system integration of electrocardiographic data and its analysis
- Clinical testing and validation of new 12-lead wireless ECG technologies
- Collaboration with Mortara engineers on new automatic ECG analysis algorithms
- Detailed clinical workflow analysis during execution of a drug study
- ECG Data management technologies for smooth transition of data to sponsors
- Secure web reporting techniques for near real-time results review
- Collaboration on promising new biomarkers for cardiac risk
"Our collaboration with Mortara helps us achieve the goal for which Spaulding Clinical Research was founded: to move the science of Phase I Cardiac Safety studies into the 21st century," said Randy Spaulding, founder of Spaulding Clinical Research. "Phase I Clinical Research Units have a profound responsibility to the Sponsors of new drugs and, ultimately, to the general public to provide extremely accurate and reliable assessment of cardiac risk. This requires better technologies. The technical and clinical ECG experience of Mortara Instrument and Spaulding Clinical Research is collectively in the hundreds of years. Why not combine the best minds in the industry for the benefit of cardiac safety?"
Spaulding is uniquely specialized to conduct Cardiac Safety Testing for new drugs in development. Spaulding provides the highest in quality clinical trial conduct, using the most efficient processes in the industry.
Justin L. Mortara, Ph.D., CEO of Mortara Instrument commented, "Working closely with Spaulding Clinical Research provides Mortara with an excellent Phase I environment to further enhance and develop our new ideas in ECG acquisition and automated workflow. Coupling our premier digital ECG collection platform with Spaulding Clinical’s hands on knowledge and experience is a promising combination."
About Spaulding Clinical
Based near Milwaukee, WI, Spaulding Clinical Research (www.SpauldingClinical.com) Spaulding Clinical is Phase 1 Clinical Research Unit and Cardiac Core Lab and offer a range of services including definitive QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect, PK/PD characterization and data collection and management. Spaulding Clinical also offers a full suite of Cardiac Core Lab and Over-reading services with state-of-the-art technology and cardiac expertise.
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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