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First Clinical Pharmacology Unit to Receive Partner Designation and to Implement Mortara's 12-Lead Telemetry System
TACOMA, Wash.--(BUSINESS WIRE)--Dec. 6, 2006--Charles River Laboratories International, Inc. (NYSE:CRL) announced today that its Clinical Services -- Northwest Kinetics unit has become the first clinical pharmacology unit (CPU) to achieve Mortara Certified Partner status and to go live with Mortara's 12-lead Surveyor Telemetry System. Charles River Laboratories Clinical Services -- Northwest Kinetics has been awarded these designations by Mortara Instrument as a result of the two companies' collaboration to significantly advance cardiac safety data acquisition and monitoring in early stage drug development.
The Mortara Certified Partner Program recognizes cardiac central laboratories and academic institutions engaged in the analysis and annotation of digital electrocardiogram (ECG) data. In collaboration with the U.S. Food and Drug Administration (FDA), Mortara has developed the E-Scribe ECG Warehouse, to receive, store and analyze cardiac safety data submitted in standardized data formats in support of New Drug Applications (NDAs). ECG data must pass a validation step in the E-Scribe ECG Warehouse system, to ensure adherence to the Health Level 7 (HL7) XML standard. FDA reviewers use the data warehouse system to process ECG data with advanced tools and viewing technologies.
As a result of the certified partner status and implementation of the 12-lead Surveyor Telemetry System, sponsors can be assured that when working with Charles River Laboratories Clinical Services -- Northwest Kinetics, ECG data will be acquired with optimized workflow and real-time monitoring of signal quality. Mortara software systems provide annotated datasets that conform to the HL7 standard and can be seamlessly imported into the E-Scribe ECG Warehouse with NDA submission. Charles River Laboratories Clinical Services -- Northwest Kinetics investigators apply uniform diagnostic standards when reading safety ECGs.
"We at Charles River Laboratories Clinical Services -- Northwest Kinetics are delighted by Mortara's special recognition. More importantly, we enjoy this unique opportunity to collaborate in moving cardiac safety forward by engineering human-device interfaces and workflow. This enables us to optimize safety, data quality, investigator oversight, and achievement of study objectives. It's a rare privilege to be more than an 'early adopter' - to be working at the forefront of technological advances," said Royce Morrison MD, MSEE, Director Medical Affairs.
Randy Spaulding, Vice-President of Clinical Research for Mortara, commented: "Congratulations to Charles River Laboratories Clinical Services -- Northwest Kinetics for not only achieving Certified Partner status, but also for being bold and innovative in recognizing the significant advantages of continuous 12-lead ECG telemetry monitoring for early stage drug studies. They have now positioned themselves to present sponsors with a complete solution for significantly reducing subject demographic errors and lost timepoints, while improving subject compliance and clinical effectiveness. The resulting FDA compliant XML data allow Northwest Kinetics to complete the cycle of managing ECG data from site acquisition all the way to FDA submission."
About Charles River Laboratories
Charles River Laboratories, based in Wilmington, Massachusetts, partners with global pharmaceutical and biotechnology companies, government agencies and leading academic institutions to advance the drug discovery and development process, bringing drugs to market faster and more efficiently. Charles River's 7,500 employees serve clients worldwide. Charles River Laboratories Clinical Services -- Northwest Kinetics is a premier early phase clinical research partner for pharmaceutical and biotechnology companies. For more information on Charles River, visit our website at www.criver.com.
Mortara Instrument's headquarters are located in Milwaukee, Wisconsin, with European operations based in Bologna, Italy. Mortara Instrument is distinguished in the field of non-invasive cardiology 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.
CONTACT: Charles River Laboratories Contacts:
Susan E. Hardy, 781-262-7616
Corporate Vice President, Investor Relations
Colleen Hoke, 253-593-5304
Director of Business Operations
Charles River Laboratories
Clinical Services -- Northwest Kinetics
Mark Mentzer, 414-354-1600
Global Director Clinical Research
SOURCE: Charles River Laboratories International, Inc.