Global biopharmaceutical services provider PAREXEL International,
has partnered with Mortara Instrument, a manufacturer and distributor of electrocardiogram, or “ECG,” devices and related technology worldwide.
The alliance is aimed to enhance PAREXEL’s cardiac safety capabilities for early phase clinical development.
Mortara is known in the field of non-invasive diagnostic cardiology systems. The company’s Instrument’s Surveyor Telemetry Central System reportedly will supplement PAREXEL’s state-of-the-art ECG equipment to support biopharmaceutical companies in improving cardiac safety assessment of new compounds. The system will allow PAREXEL to acquire and store continuous, diagnostic 12-lead ECG data, which is wirelessly transmitted from devices worn by clinical trial participants.
Mortara’s Surveyor Telemetry Central System has been designed to address the growing ECG requirements of early phase cardiac safety studies. The system has been fully implemented and validated in PAREXEL’s early phase clinical unit located in Baltimore, Maryland in the United States.
This solution extends the technology capabilities for ECG and QT/QTc studies conducted in PAREXEL’s other early phase units worldwide, and provides live monitoring and automated acquisition and recording of ECGs for analysis and transmission to core labs.
Michelle Middle, MB ChB, corporate vice president and worldwide head of early phase, PAREXEL, said that this agreement provides customers with improved automation in the acquisition and reporting of ECG data for greater data accuracy and faster, better decision making.
She added that this agreement validates their commitment to providing comprehensive early phase cardiovascular expertise and capabilities.
According to PAREXEL’s officials, each of their early phase clinical units has state-of-the-art equipment. These unites are known to perform cardiac studies according to international guidelines and are equipped with telemetric and bedside monitoring as well as ECG equipment for continuous registration.
The company has experienced early phase experts that specializes in providing top-quality, evidence-supported readings of clinical cardiovascular data and work in collaboration with ECG core labs.
Anuradha Shukla is a contributing editor for HealthTechZone. To read more of Anuradha’s article, please visit her columnist page.Edited by
Kelly McGuire