BOSTON, Sept. 23 /PRNewswire-FirstCall/ -- PAREXEL International Corporation , a leading global biopharmaceutical services provider, today announced that the Company has expanded its early phase drug development capabilities to provide biopharmaceutical companies with dedicated support for Proof of Concept studies. PAREXEL's new Proof of Concept unit integrates expertise and capabilities in regulatory strategies, drug development, and clinical pharmacology. Proof of Concept studies are mainly conducted in targeted patient populations and are designed to demonstrate early signals of a product's efficacy. The goal of these studies is to help clients avoid costly late stage clinical development failures by making better and faster go/no-go decisions
"As the biopharmaceutical industry explores new development paradigms to bring safe and effective treatments to market more efficiently, companies are conducting a growing number of complex and rigorous Proof of Concept studies. Providing clients with integrated, early phase development strategies and expertise gives them the ability to support early identification and selection of the most promising compounds," said Herman Scholtz, M.D., Corporate Vice President, Early Drug Development, PAREXEL.
PAREXEL's dedicated team of experts provides clients with the required scientific, therapeutic, and regulatory expertise to design and implement Proof of Concept studies for new drug entities across a broad range of therapeutic indications. This team offers customized solutions including the appropriate use of biomarkers and adaptive trial designs. Adaptive designs are supported by specialized biostatistical expertise and eClinical technology capabilities. Relevant technologies include Interactive Voice and Web Response Systems (IVRS/IWRS) to randomize patients and track drug inventory as well as electronic data capture to provide rapid access to study data.
To accelerate patient recruitment, the Proof of Concept service offering provides PAREXEL SuperSites(SM) capabilities in combination with a broad, global network of investigator and academic sites. PAREXEL SuperSites solutions leverage PAREXEL's hospital-based Clinical Pharmacology Research Units to provide high patient enrollment potential, drawing on dedicated recruitment specialists and relationships with local, hospital-based physicians as well as using on-site call centers and database capabilities. This allows for a high number of patients to be recruited at these units in a shorter time frame, reducing the overall number of investigator sites, and ultimately decreasing time and cost.
For more information about PAREXEL's early phase development capabilities, visit: http://www.parexel.com/early_phase.html.
About PAREXEL
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 69 locations throughout 52 countries around the world, and has approximately 8,800 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 (including ClinPhone) 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 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 their respective business and are hereby acknowledged. SuperSites is a service mark of PAREXEL International Corporation.
CONTACT: Jennifer Baird, Senior Director of Public Relations of PAREXEL
International, +1-781-434-4409, Jennifer.Baird@PAREXEL.com; or Rebecca
Passo of SHIFT Communications for PAREXEL International Corporation,
+1-617-779-1817, rpasso@shiftcomm.com
Web site: http://www.parexel.com/
