BOSTON, Oct. 29 /PRNewswire-FirstCall/ -- PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, in partnership with Glenmark Pharmaceuticals Ltd, today announced that it has been recognized by the Good Clinical Practice Journal (GCPj) as the winner of its Most Innovative Patient Recruitment Strategy Award. The award recognizes the impressive collaborative efforts of PAREXEL and study sponsor Glenmark, a research-driven innovation-led organization that focuses on delivering new molecules, in taking an innovative approach to accelerating study timelines. This approach substantially helped Glenmark make earlier, more effective decisions about a novel diabetes compound by incorporating a combined protocol design into an early phase clinical development program, which is now progressing well in Phase IIb. The program also leveraged PAREXEL's unique, global early phase patient recruitment strategies.
According to Helena Jensen, Publisher of the Good Clinical Practice Journal, "We are pleased to recognize PAREXEL for its outstanding expertise in volunteer and patient recruitment as well as its novel approaches in early phase development. PAREXEL has demonstrated the kind of innovation that is required in partnering with biopharmaceutical companies to help them address growing study complexity, avoid late stage failures, use rapid recruitment access methods, and bring important, safe and effective treatments to the market."
"Our global clinical pharmacology team worked with Glenmark to develop an innovative way to accelerate recruitment, leverage global strategies, and use regulatory submission timelines to full advantage for the company's clinical development program," said Michelle Middle, MB ChB, Corporate Vice President and Worldwide Head of Clinical Pharmacology at PAREXEL. "We are honored to receive this award in partnership with Glenmark from GCPj, which recognizes the in-depth expertise that PAREXEL brings to bear to help clients identify and select the most promising compounds, and make better and faster go/no-go decisions."
The early phase development program included evaluating the safety, tolerability, pharmacokinetic, and pharmacodynamic effects in healthy volunteers in single and multiple ascending dose Phase I studies. The Phase I studies were followed by a Proof of Concept study in 60 patients with Type II diabetes. The multi-site program used three of PAREXEL's Clinical Pharmacology Research Units in London, England, and in Bloemfontein and George, South Africa. Global patient recruitment strategies and the combined protocol developed by PAREXEL and Glenmark contributed to accelerating development timelines and exceeding milestone targets. Results included enabling Glenmark to make a go/no-go decision seven months earlier and complete the program 30 percent faster than is typical during early phase drug development.
For more information about PAREXEL's early phase development capabilities visit: http://www.parexel.com/early_phase.html.
The Good Clinical Practice Journal Awards Ceremony was held October 22, 2008 at the Banqueting House in London. Additional information about the awards and winners can be found at http://www.gcpjawards.com. Good Clinical Practice Journal (GCPj) (http://www.gcpj.com) addresses the regulatory, strategic, and clinical issues that directly impact clinical studies globally.
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 71 locations throughout 52 countries around the world, and has over 9,180 employees. For more information about PAREXEL International visit http://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 Annual Report on Form 10-K for the Fiscal Year ended June 30, 2008 as filed with the SEC on August 28, 2008, 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.
Jennifer Baird, Senior Director of Rebecca Passo
Public Relations SHIFT Communications
PAREXEL International Tel: +617-779-1817
Tel: +781-434-4409 Email: email@example.com
|SOURCE PAREXEL International Corporation|
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