PAREXEL Introduces New Technology Platform to Bring Greater Efficiency to Late Phase Studies
The solution integrates the innovative strategies and proven processes of PAREXEL's PACE(TM) (Peri Approval Clinical Excellence) team with eClinical solutions from Perceptive Informatics, PAREXEL's technology subsidiary. This approach helps biopharmaceutical companies ensure higher data quality, accelerate better decision-making, and achieve faster determination of evidence-based health outcomes in late phase clinical research.
"Post-approval studies have continued to expand measurably in number, size, and complexity in recent years. As a result, biopharmaceutical companies require much greater efficiency in managing the high volume throughput of data while controlling the costs related to these programs. We are focused on helping clients achieve greater efficiency by gathering more data at a significantly lower cost per patient," said Carol Collins, Ph.D., Corporate Vice President and Worldwide Head of PACE, PAREXEL International.
According to Dr. Collins, "A variety of late phase studies, including observational studies and patient registries, are being used as either primary or adjunct vehicles for pharmacovigilance and health evaluation activities in order to meet increasing regulatory and payer demands for long-term safety and health outcomes data. This new technology platform reinforces our commitment to assist clients in generating more robust product safety and heath outcomes profiles."
The platform includes many features and benefits to bring greater efficiency to late phase studies, such as:
The platform allows for a broad range of eClinical solutions, such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), and Electronic Patient-Reported Outcomes (ePRO), to be incorporated in late phase studies for optimal data integration.
PAREXEL's PACE(TM) (Peri Approval Clinical Excellence) team provides customized strategic and scientific solutions to facilitate the transition from product development to commercialization in a seamless and cost-effective manner. Over the past five years, the PACE team has conducted over 600 late phase studies, throughout 76 countries, which have involved more than one million patients and over 90,000 physician sites. PAREXEL's late phase capabilities include Phase IIIb and IV clinical trials, observational studies, registries, expanded access programs, risk management programs, post approval safety surveillance, and comparative effectiveness research as well as health economics and outcomes research consulting. For more information, visit: http://www.PAREXEL.com/Late_Phase.html.
Note: Randomization and Trial Supply Management (RTSM) solutions incorporate functionality that is often referenced as Interactive Voice and Web Response Systems (IVRS/IWRS).
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 71 locations throughout 50 countries around the world, and has approximately 9,200 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, including the anticipated restructuring charge of approximately $30 million over the second and third quarters of Fiscal Year 2010; 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, 2009 as filed with the SEC on February 5, 2010, 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.
-- A streamlined user experience with single access -- An intuitive interface with functionality for site self registration and management -- Automated cues for unique late phase site requirements to enable improved compliance -- Enhanced reporting capabilities including site-based features such as investigator payment status reports -- Centralized access to data including site, patient, and clinical supply information
SOURCE PAREXEL International Corporation
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