PAREXEL ENHANCES EARLY PHASE CARDIAC SAFETY CAPABILITIES THROUGH ALLIANCE WITH MORTARA INSTRUMENT
Boston, MA, November 9, 2009—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; and Berlin, Germany.
“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.
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 about PAREXEL’s early phase capabilities visit: http://www.PAREXEL.com/Early_Phase.html.
Mortara, which is distinguished in the field of non-invasive diagnostic cardiology systems, has a long-standing relationship with the U.S. Food and Drug Administration (FDA), providing ECG algorithm tools and data warehousing solutions to support regulatory review of cardiac safety data. Since 2006, FDA has been using Mortara’s ECG Warehouse and toolset to review thorough QT studies. Mortara Instrument manufactures and distributes its ECG devices and related technology worldwide. The company's website is www.mortara.com.
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About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 70 locations throughout 52 countries around the world, and has more than 9,130 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 as filed with the SEC on November 6, 2009, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.