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Perceptive Informatics (PRXL) Global Survey Results Show Growing Industry Interest in Implementing Adaptive Trial Designs


4/25/2011 8:17:55 AM

BOSTON, April 25, 2011 /PRNewswire/ -- Perceptive Informatics, the industry's leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced results of a global survey conducted during its recent webinar entitled "Implementing Bayesian Response Adaptive Trials." The webinar, presented by Perceptive Informatics with Tessella, was attended by over 300 professionals from the biopharmaceutical industry across a broad range of clinical, statistical and regulatory functions. Perceptive polled these professionals about their plans for the implementation of adaptive clinical trial designs.*

The survey results revealed that 80% of respondents are considering the implementation of some type of adaptive design over the next 12 months. Of these respondents, the majority (76%) are considering designs that drop treatment arms at fixed interim analyses. Fewer respondents (24%) expect to implement designs that regularly adjust the randomization ratio throughout the study. This approach is referred to as a response adaptive design.

"Following the FDA draft guidance on adaptive trials, increasing implementation of these designs has helped to alleviate regulatory acceptance concerns within the industry," said Damian McEntegart, Senior Director of Statistics and Product Support, Perceptive Informatics. "An important requirement for adaptive trials is the ability to include more dose levels in Phase II dose-finding studies without significantly increasing the number of study participants or the length of timelines. Perceptive Informatics is committed to driving the industry in using eClinical solutions to support complex adaptive trial designs and their associated supply management challenges. We are focused on helping the industry to successfully implement adaptive trials, which can enable better decision-making about compounds and reduce the time between development phases."

Perceptive Informatics, which has supported the implementation of over 100 adaptive trials, provides interoperable eClinical solutions from its eClinical Suite, including Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM) technologies, and Electronic Patient Reported Outcomes (ePRO). The Perceptive eClinical Suite facilitates access to the real-time, consolidated data required in adaptive trial designs. Services provided by Perceptive Informatics experts in the area of adaptive trial design include:

  • Study design consultation
  • Supplies forecasting and simulation
  • Implementation of technologies to manage randomization, trial adaptations and supply inventories

For more information about capabilities from Perceptive to support adaptive trials visit: http://www.perceptive.com/solutions/adaptive-trials/. For more information about Perceptive's strategic alliance partner Tessella, which provides specialized statistical applications, visit: http://www.smarterclinicaltrials.com/.

*According to the draft guidance from the U.S. Food and Drug Administration (FDA) "Adaptive Design Clinical Trials for Drugs and Biologics" clinical trials can be designed with adaptive features, such as changes in design or analyses guided by examination of accumulated data at an interim point in the trial, that may make the studies more efficient, more likely to demonstrate an effect of the drug if one exists, or more informative by providing broader dose-response information.

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 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 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 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 10,380 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," "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 quarter ended December 31, 2010 as filed with the SEC on February 9, 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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