PAREXEL Expands Post Marketing Surveillance Service in Japan
New service model offers simple, cost-effective approach to support long term PMS requirements for pharmaceutical and medical device products launched in Japan
Boston, MA, U.S., June 20, 2013 --PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced the expansion of its PACE™ (Peri-Approval Clinical Excellence) group service offering to help global and Japan-based biopharmaceutical companies registering their products in Japan to fulfill regulatory Post Marketing Surveillance (PMS) requirements. The services, fully localized to the unique requirements of Japanese PMS, include a range of site monitoring and site support activities, data management and programming, statistical analysis and pharmacovigilance.
“Increasing regulatory demands for long-term safety data on pharmaceutical products has contributed to an exponential increase in the number of peri approval studies across Asia,” said Carol Collins, Ph.D., Corporate Vice President and Worldwide Head of PACE at PAREXEL. “PAREXEL offers a cost-effective and user-friendly operating model that can improve PMS compliance and data quality. This helps to create more effective utilization and maximize market penetration for biopharmaceutical companies.”
PAREXEL believes that its PACE™ group is positioned to extend its proven processes, customized tools and technologies to clients in the Asia/Pacific region, allowing them to move from product development to commercialization seamlessly and cost-effectively. Japanese PMS services will be supported by highly experienced and multilingual subject matter experts across Japan, China and Taiwan who understand the regulatory environment and current market dynamics in the region.
PAREXEL’s PACE business in Japan takes advantage of its highly educated and skilled staff to quickly and flexibly adjust resources that support the unique needs of long-term PMS and observational study requirements in Japan. The latest web reporting tools are incorporated to allow clients the freedom to track study progress and review live study metrics.
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About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications 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 78 locations throughout 52 countries around the world, and has approximately 14,400 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," "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 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 fiscal quarter ended March 31, 2013 as filed with the SEC on May 6, 2013, 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.
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.