PERCEPTIVE INFORMATICS® TAKES LEAD IN PRACTICAL APPLICATION OF RESPONSE CRITERIA FOR LYMPHOMA AND LEUKEMIA IN CLINICAL TRIALS
BOSTON, MA, June 9, 2011 — 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.
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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.
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