CLINILABS IMPLEMENTS FIRST EAST-COAST INSTALLATION OF THE MORTARA SURVEYOR 12-LEAD TELEMETRY SYSTEM
State-of-the-art Integrated Core ECG Lab and Phase 1 Cardiac Safety Unit Now Open
NEW YORK, NY – January 10, 2008 – The first East-Coast installation of the Surveyor 12-lead Telemetry System from Mortara Instrument, Inc. was utilized in a cardiovascular safety study in Clinilabs’ Integrated Core ECG Lab and Phase 1 Unit. Clinilabs is unique among providers of cardiac safety and cardiovascular drug development services, providing collection, analysis and data management of cardiovascular bioelectronic signals all within its 60-bed, state-of-the-art cardiac safety unit in Manhattan. Collection and analysis of data such as ECGs within one site provides for greater security and faster turnaround of data analysis.
The Surveyor 12-lead Telemetry System was installed at Clinilabs’ state-of-the-art Clinical Research Unit (CRU) in May 2007 and served as the data collection and clinical monitoring solution for a cardiac safety study of an early stage product. The Surveyor system supports continuous diagnostic 12-lead ECG data collection while simultaneously enabling real time subject monitoring for arrhythmias and other events.
“Sponsors don’t want added risk – and neither do we. The Surveyor 12-lead telemetry system is not merely a system to minimize clinical risks. The Surveyor assures us of a complete duplicate of the electrocardiographs over the entire observation period. So if a Holter recorder malfunctions or a device is lost in shipping, we provide sponsors the lowest possible risk of missing data,” stated Jonathan Sackner-Bernstein, M.D., F.A.C.C., Clinilabs’ Chief Medical Officer.
We are very pleased to have established a partnership with Clinilabs, which includes deployment of the Surveyor Telemetry Central System.” Dr. Justin L. Mortara, Ph.D., Vice President, Mortara Instrument stated. Mortara also noted, “Their adoption of the Surveyor 12-lead Telemetry System, integrated with Mortara's suite of cardiac safety solutions, provides Clinilabs with a significant competitive advantage in serving sponsors needing to conduct thorough-QT studies. The Surveyor system, coupled with Clinilab's talented internal team and state of the art facility, will make them a compelling choice for sponsors evaluating cardiac safety of new compounds.”
“Mortara’s leadership in ECG central laboratory solutions and their advanced 12-lead telemetry solution will assist us in providing quality drug development services to our clients as we continue to grow and expand our capabilities,” commented Dr. Gary K. Zammit, Chief Executive Officer and President, Clinilabs.
Clinilabs is a global, specialty CRO that provides clinical development services to life science companies involved in the development of central nervous system (CNS) and cardiovascular therapeutics, as well as compounds in early clinical development. The Company offers a robust portfolio of services including data management, scientific consulting, protocol writing, project management, study monitoring, statistics, and reporting. And clients utilize these services across the entire course of product development including the Company's dedicated, 60-bed Phase 1 unit for early-phase development, proof-of-concept, or cardiac safety studies; access to its international panel of certified investigators for multicenter studies; and its multi-million dollar electronic data center, which provides a comprehensive range of Part 11-compliant electronic data capture and management services, including the processing of eCRF, clinical laboratory, IVRS, ePRO, EEG, quantitative EEG, EMG, ECG, ABP, and actigraphy data.
Established in 2001, Clinilabs has provided a portfolio of clinical trial services that reduce the stress, time, cost, and risk associated with the development of new therapeutics. The company provides these services with dedication to exceptional client service, high quality clinical care, and patient safety. The Company’s website is www.clinilabs.com.
Mortara Instrument, Inc, based in Milwaukee, WI, 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 and data warehousing solutions, and cardiology monitoring systems. The Company’s website is www.mortara.com.
Mennato Forgione, Director of Business Development, Clinilabs, Inc.
mforgione@clinilabs.com, 212-994-4141
Mark Mentzer, Vice President, Clinical Research Mortara Instrument, Inc.
Mark.Mentzer@mortara.com, 414-354-1600
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