PAREXEL International forms an alliance with Mortara Instrument, enhances cardiac safety capabilities

PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, today announced that it has enhanced its cardiac safety capabilities for early phase clinical development through an alliance with Mortara Instrument, Inc., which manufactures and distributes electrocardiogram (ECG) devices and related technology worldwide. PAREXEL is using Mortara Instrument's Surveyor Telemetry Central System to supplement its state-of-the-art ECG equipment to support biopharmaceutical companies in improving cardiac safety assessment of new compounds.

Designed to address the growing ECG requirements of early phase cardiac safety studies, Mortara's Surveyor Telemetry Central System allows PAREXEL to acquire and store continuous, diagnostic 12-lead ECG data, which is wirelessly transmitted from devices worn by clinical trial participants. The Mortara solution, which has been fully implemented and validated in PAREXEL's early phase clinical unit located in Baltimore, Maryland in the United States, provides live monitoring and automated acquisition and recording of ECGs for analysis and transmission to core labs. This solution extends the technology capabilities for ECG and QT/QTc studies conducted in PAREXEL's other early phase units worldwide, including sites located in Los Angeles, California in the United States as well as in London, United Kingdom; Berlin, Germany; and Bloemfontein, George, and Port Elizabeth, South Africa.

"With growing regulatory requirements, cardiac safety studies have become increasingly important within a clinical development program. We help biopharmaceutical companies gather cardiac safety data early in the development cycle for maximum efficiency," said Michelle Middle, MB ChB, Corporate Vice President and Worldwide Head of Early Phase, PAREXEL International. "Our alliance with Mortara Instrument provides customers with improved automation in the acquisition and reporting of ECG data for greater data accuracy and faster, better decision making. This relationship represents our commitment to providing comprehensive early phase cardiovascular expertise and capabilities, such as intensive ECG and thorough QT/QTc studies, supported by enabling technologies."

Each of PAREXEL's early phase clinical units has state-of-the-art equipment and performs cardiac studies according to international guidelines. The units are equipped with telemetric and bedside monitoring as well as ECG equipment for continuous registration. PAREXEL's early phase experts provide top-quality, evidence-supported readings of clinical cardiovascular data and work in collaboration with ECG core labs. PAREXEL's early phase services include a wide range of cardiovascular-related capabilities, including study design, project monitoring, data management, and biostatistics.