December 6, 2006

Charles River Laboratories Clinical Services -- Northwest Kinetics Achieves Mortara Certified Partner Status

Charles River Laboratories 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."

Return to Previous Page

What's New

Charles River Laboratories Clinical Services -- Northwest Kinetics Achieves Mortara Certified Partner Status

Charles River Acquires Northwest Kinetics

All news items

 Charles River Home | Careers | Humane Care | Events | News Room | Investor Relations | Site Index | Contact