BARNETT RELEASES GOOD CLINICAL PRACTICE TRAINING GUIDE
PHILADELPHIA, PA, May 18, 2004 — Barnett International, a division of PAREXEL International Corporation (Nasdaq: PRXL), has announced the release of Good Clinical Practice: A Question & Answer Reference Guide 2004 (Second Edition). Designed for clinical research associates, managers and trainers, as well as investigators, site staff, trial sponsors, and regulatory affairs professionals, the handbook has been expanded and updated to answer close to 400 of today’s most common, pressing, and difficult questions regarding the interpretation and implementation of evolving Good Clinical Practice (GCP) standards.
Developed with input from over 100 industry and government clinical trial and GCP experts, the Reference Guide specifically targets emerging issues in the day-to-day interpretation and implementation of GCP standards for drug, biologics, and medical device trials. The Reference Guide addresses 22 critical areas in clinical research, including the differences between FDA and ICH GCP standards, evolving Part 11 and HIPAA requirements, clinical monitoring, principal investigator and site staff responsibilities, adverse experience reporting, informed consent, researcher conflicts of interest, and source data and documentation. In addition, the Reference Guide provides key FDA regulations and standards, as well as the Consolidated ICH GCP guideline, and essential international GCP-related documents, including Europe’s Clinical Trial Directive.
Good Clinical Practice: A Question & Answer Reference Guide is co-authored by leading experts in GCP standards and compliance and clinical trial auditing, including Douglas Mackintosh and Vernette Molloy of GCPA, Inc., and Mark Mathieu of PAREXEL International Corporation. The Reference Guide is available from Barnett Educational Services for $24.95 per copy by calling Customer Service at 610-565-2622, x2200 or by ordering online at www.barnettinternational.com.
Barnett International is an operating unit of PAREXEL International Corporation, 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 52 locations throughout 36 countries around the world, and has 5,015 employees.
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. 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; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth, 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; 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 the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2004 as filed with the SEC on May 13, 2004, 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.