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Perceptive Informatics (PRXL) Takes Lead in Practical Application of Response Criteria for Lymphoma and Leukemia in Clinical Trials


6/9/2011 6:59:48 AM

BOSTON, June 9, 2011 /PRNewswire/ -- Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced that it is taking a lead role in the biopharmaceutical industry to advance the practical application of revised response criteria for Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) to clinical trials. Bruce D. Cheson, M.D., Medical Imaging Scientific Advisor, Perceptive, who chairs the Lymphoma Committee of the Cancer and Leukemia Group B and American Joint Committee on Cancer (AJCC) Subcommittee on Lymphoma, is working with the Perceptive Medical Imaging Group on standardizing and harmonizing the criteria across investigative sites and central reviewers for the assessment of patients.

According to Dr. Cheson, "Perceptive is a leader in bringing practical approaches to the implementation of standardized guidelines for assessing response to treatment of hematologic malignancies. This major step is valuable to Perceptive's clients in their imaging-based oncology and hematology clinical trials, with regard to the application of the assessment criteria for NHL and CLL." Dr. Cheson is an author on the widely accepted assessment criteria for NHL (1999 and 2007 IWG-NHL) and CLL (1996 NCI-WG and 2008 IWCLL), which are standardized guidelines for assessing response to treatment.

Perceptive Informatics has introduced its NHL/CLL Product Program to support the implementation of these criteria in clinical trials. Dr. Cheson, Professor of Medicine, Deputy Chief, Division of Hematology-Oncology, and Head of Hematology at the Georgetown University Hospital Lombardi Comprehensive Cancer Center, together with the expert medical team in the Perceptive Medical Imaging Group are helping to advance understanding of the guidelines to provide clinicians worldwide with consistent criteria to compare and interpret clinical trials in hematology and oncology indications -- with the goal of facilitating the development of new treatments. Perceptive experts bring an in-depth understanding of the criteria for harmonization across clinical trials. Perceptive develops analysis applications to enhance the review process and workflow for studies using the NHL/CLL analysis criteria to validate clinical trial data.

The Perceptive whitepaper entitled "Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials" provides clarifications for applying the revised criteria in clinical trials, with a particular emphasis on protocols and independent review analysis. To access the whitepaper and for more information on NHL and CLL assessment criteria visit: http://www.perceptive.com/imaging/criteria-experience.

About Perceptive Informatics

Perceptive Informatics, a leading eClinical solutions provider and subsidiary of PAREXEL, is focused on helping customers to accelerate the product development process through innovation. Perceptive enables customers to maximize the benefits of clinical trial technologies by providing flexible software-as-a-service (SaaS) applications and leading technology services. The Perceptive Informatics eClinical Suite is built on extensive medical and clinical expertise, as well as a deep understanding of the regulatory environment. The suite includes Randomization and Trial Supply Management (RTSM) technologies, Medical Imaging, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Electronic Patient-Reported Outcomes (ePRO). The Perceptive Informatics eClinical Suite blurs the boundaries among systems that traditionally have been used in isolation, resulting in simplified workflow, improved efficiency and enhanced productivity. For more information about the integrated solutions in the Perceptive Informatics eClinical Suite visit www.perceptive.com.

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 71 locations throughout 52 countries around the world, and has approximately 10,350 employees. For more information about PAREXEL International visit www.PAREXEL.com.

This release contains "forward-looking" statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. 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, including the anticipated restructuring charge of approximately $15 million over the fourth quarter of Fiscal Year 2011 as well as the first and second quarters of Fiscal Year 2012; 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 quarter ended March 31, 2011 as filed with the SEC on May 10, 2011, 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.

Contacts:


Jennifer Baird, Senior Director of Public Relations

Gene Carozza/Kim Baker

PAREXEL International

PAN Communications

Tel: +781-434-4409

Tel: +978-474-1900

Email: Jennifer.Baird@PAREXEL.com

Email: PAREXEL@pancomm.com



SOURCE PAREXEL International Corporation


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