BOSTON, May 20, 2014 -- PAREXEL International (NASDAQ: PRXL), a leading global biopharmaceutical services organization, today announced the launch of its Perceptive MyTrials® Data-Driven Monitoring solution. Developed by PAREXEL Informatics, it is a key component of the Perceptive MyTrials eClinical platform, an integrated suite of applications for managing clinical trials.
On-site monitoring is a critical aspect of trial management, with the primary function of identifying and mitigating patient safety or data quality risks at investigative sites. The U.S. Food and Drug Administration (FDA) and other regulatory bodies have issued guidance to assist sponsors in developing risk-based monitoring strategies that enhance patient protection and improve trial data quality through more effective study oversight. They have encouraged greater use of centralized monitoring methods to evaluate clinical trial conduct and progress.
PAREXEL's new data-driven monitoring solution provides an innovative approach to centralized risk-based monitoring. The technology captures, consolidates and organizes clinical information in real-time from disparate sources. As a result, drug developers can accurately identify study risks and rapidly determine what type of intervention may be required. Monitoring focused on specific risk offers the potential to enhance patient safety, reduce costs and promote regulatory compliance.
"Perceptive MyTrials Data-Driven Monitoring uses clinical data to guide monitoring activities as an alternative to periodically scheduled monitoring visits, which can be time-consuming, costly and inefficient," said Xavier Flinois, President of PAREXEL Informatics. "Greater insight into study data allows for a more precise determination of when on-site monitoring visits need to occur and what activities should be undertaken during those visits. This can make clinical trial participation safer for patients while offering cost efficiencies for sponsors."
"Our data-driven monitoring solution builds on PAREXEL's long-standing track record of developing innovative technologies to continuously improve clinical processes," said Mark A. Goldberg, M.D., President and Chief Operating Officer, PAREXEL. "Perceptive MyTrials Data-Driven Monitoring represents the latest example of our leadership in bringing efficiencies to the drug development process."
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, medical communications, and technology solutions and 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 75 locations in 50 countries around the world, and has approximately 15,335 employees. For more information about PAREXEL International visit www.PAREXEL.com.
PAREXEL, PAREXEL Informatics, Perceptive, Perceptive MyTrials, and "Your Journey. Our Mission." are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates.
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," "will," "would," "could," "should," "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 and anticipated 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 including the recent acquisitions of LIQUENT, Inc. and HERON Group Ltd., Inc., or enter into new lines of business; 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 March 31, 2014 as filed with the Securities and Exchange Commission (SEC) on May 2, 2014, which "Risk Factors" discussion is incorporated by reference in this press 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.
Diana Martin, Vice President, Corporate Communications
Tel: +1 781-434-5516
Email: [email protected]
Tel: +1 617-502-4300
Email: [email protected]