NEW RESOURCE GUIDE FIRST TO ADDRESS KEY PART 11 QUESTIONS FOLLOWING RECENT SHIFT IN FDA APPROACH
PHILADELPHIA, PA, March 15, 2004 — Barnett Educational Services, a division of PAREXEL International Corporation (Nasdaq: PRXL), announces the release of the new reference manual, Part 11 and Drug Development: A Q&A Reference Guide, the first text to analyze the implications of the recent shift in the Food and Drug Administration’s (FDA) approach to Part 11 requirements. Specifically designed for clinical, regulatory, quality assurance and other drug development professionals, this new pocket-sized handbook provides answers to the most common, emerging, and difficult questions regarding the FDA’s new approach to the Part 11 guidance.
Authored by industry experts, the new Part 11 and Drug Development: A Q&A Reference Guide addresses the most difficult and confusing questions regarding the scope and implementation of current Part 11 guidance. For those directly involved in drug development, the reference guide outlines Part 11’s applicability from standard clinical trial practices to regulatory practices, from advanced electronic data capture (EDC) systems to basic email systems, and from electronic signatures to electronic record retention.
Part 11 and Drug Development: A Q&A Reference Guide is available for $24.95 per copy by calling 800-856-2556 x2301 or by ordering online at www.barnettinternational.com.
PAREXEL is one of the largest biopharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that expedite time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. Its information technology subsidiary, Perceptive Informatics, Inc., develops and offers a portfolio of innovative technology-based products and services that facilitate clinical drug development and are designed to decrease time to peak sales. The technology portfolio includes web-based portal solutions and tracking tools, Interactive Voice Response Systems (IVRS), Clinical Trial Management Systems (CTMS), electronic diary and investigator database solutions. Perceptive also offers advanced medical diagnostics services to assess rapidly and objectively the safety and efficacy of new drugs, biologics, and medical devices in clinical trials. PAREXEL’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 57 locations throughout 37 countries around the world, and has 5,050 employees.
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 their respective owners and are hereby acknowledged.
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" and similar expressions are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. PAREXEL'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; PAREXEL's dependence on certain industries and clients; PAREXEL's ability to win new business, manage growth, and attract and retain employees; PAREXEL's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry; 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 PAREXEL’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2003 as filed with the SEC on February 10, 2004, which "Risk Factors" discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent PAREXEL’s estimates as of the date of this release. PAREXEL specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing PAREXEL’s estimates or views as of any date subsequent to the date of this press release.