PERCEPTIVE INFORMATICS SURVEY RESULTS REVEAL TOP BARRIERS TO IMPLEMENTING ADAPTIVE TRIAL DESIGNS
Boston, MA, May 4, 2009 – Perceptive Informatics, the industry’s leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced the results of a survey conducted during its recent webinar entitled “Optimizing Adaptive Trial Designs: Using Simulation Methodologies to Overcome Challenges.” The webinar, conducted by Perceptive Informatics with partner Cytel Inc., a provider of specialized statistical applications, was attended by over 500 professionals from the biopharmaceutical industry, across a broad range of clinical, statistical, and regulatory functions. The survey results identified regulatory acceptance concerns, lack of understanding about new techniques, and ability to rapidly access clinical endpoint data as the top barriers to the implementation of adaptive trials.
Respondents to the survey were able to choose more than one category. Regulatory acceptance concerns were cited by more than 35% of respondents, followed by lack of understanding about new techniques (over 33%) and rapid access to clinical endpoint data (over 28%). Other barriers to implementing adaptive trial designs that were cited by respondents included understanding and implementing complex statistical methodologies as well as difficulties in medication supplies estimation and supply chain management.
“Formal FDA guidance on adaptive trials implementation is expected later this year and should help to alleviate regulatory acceptance concerns. As biopharmaceutical companies focus on making reliable decisions as early as possible in drug development, a growing area 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 timeline required. Perceptive is committed to assisting the industry in gaining more experience in effectively implementing adaptive trials using technologies to support these complex designs and their associated supply management challenges,” said Bill Byrom, Ph.D., Senior Director, Product Strategy, Perceptive Informatics.
Perceptive Informatics, which has supported the implementation of over 100 adaptive trials, provides eClinical solutions, including Electronic Data Capture (EDC), Interactive Voice and Web Response Systems (IVRS/IWRS), and Electronic Patient Reported Outcomes (ePRO), which are important to supporting the consolidated information required in adaptive trial design. 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
- Electronic collection of clinical response data
Perceptive’s products and services are complemented by adaptive trial expertise provided by other business units of PAREXEL, including Clinical Research Services, and an established partnership with Cytel. For more information about capabilities from Perceptive to support adaptive trials visit: http://www.perceptive.com/product/ivrs/adaptive-trials.html.
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About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry’s leading eClinical solutions provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the efficiency and productivity of clinical research. Perceptive’s expansive product portfolio includes Interactive Voice and Web Response Systems (IVRS/IWRS), Medical Imaging, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and Electronic Patient Reported Outcomes (ePRO) solutions, as well as eClinical systems integration and implementation services. For more information about Perceptive Informatics, visit www.perceptive.com.
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 69 locations throughout 52 countries around the world, and has over 9,400 employees. For more information about PAREXEL International visit 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 Quarterly Report on Form 10-Q for the quarter ended December 31, 2008 as filed with the SEC on February 9, 2009, 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.