November 9, 2009 — PAREXEL International Corp., a global biopharmaceutical services provider, announced today 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, 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, London, Berlin, and Bloemfontein, George, and Port Elizabeth, South Africa.
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.
PAREXEL's early-phase services provide fully integrated solutions from first in man through proof of concept and help biopharmaceutical companies generate better and faster go/no-go decisions about their compounds, and strive to return solid, reproducible outcomes to succeed in later-phase trials. PAREXEL's early phase capabilities include a full scope of early phase studies, specialized trial design, state-of-the-art technologies, hospital-based resources, and scientific expertise as well as vast experience in the neurology, cardiology, respiratory, and metabolism/endocrine therapeutic areas. With early phase unit locations across three continents, PAREXEL provides rapid study start-up and access to diverse patient populations in addition to healthy volunteers.
For more information: www.parexel.com/Early_Phase.html, www.mortara.com