PAREXEL ANNOUNCES NEW MEDICAL AND SCIENTIFIC OFFERING - PHARMACOVIGILANCE & POST-APPROVAL SERVICES
BOSTON, MA, April 6, 2000 — PAREXEL International Corporation (Nasdaq: PRXL) today announced the launch of Pharmacovigilance & Post-Approval Services, a new offering of the Clinical Research Services division. These important new services are designed to provide pharmaceutical, biotechnology and medical device companies with an improved ability to monitor and assess the safety of their marketed products. Pharmacovigilance refers to the practice of monitoring the safety of pharmaceuticals throughout clinical testing and market introduction. In the U.S. and in Europe, all companies conducting clinical research or marketing medical products have a regulatory obligation to monitor and evaluate safety concerns reported for their products. PAREXEL now offers to clients an outsourcing solution ranging from expert consultation to the full management and evaluation of safety reports.
"The recent implementation and enforcement of European Union and FDA guidelines make it even more important for all companies to perform effective global pharmacovigilance," stated Josef von Rickenbach, Chairman and CEO of PAREXEL. "As a global Contract Research Organization, PAREXEL possesses a wealth of experience in clinical trials, drug safety, data management and regulatory affairs, so it is a logical extension for us to offer these new capabilities. To our knowledge, no one else provides the extensive range of capabilities that we do in this area."
Leading these services is Brian Edwards, M.D., Senior Director of Pharmacovigilance Services. Dr. Edwards possesses nearly twenty years of experience in clinical medicine, clinical research and pharmacovigilance. He is well qualified to guide and consult with companies regarding pharmacovigilance issues. Having dealt with a wide range of products within the European regulatory framework while at the Medicines Control Agency, he has been deeply involved in some of the largest pharmacovigilance issues. Dr. Edwards is widely regarded as an expert in the field of pharmacovigilance and drug device safety services.
This release may contain "forward-looking" statements regarding future results and events, including statements regarding expected future growth and customer demand. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Factors that might cause such a difference include, but are not limited to, risks associated with: the loss or delay of large contracts; the Company's dependence on certain industries and clients; the Company's ability to manage growth and its ability to attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses; government regulation of certain industries and clients; competition and consolidation within the 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. These 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, 1999. PAREXEL is one of the largest contract pharmaceutical 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 accelerate 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. The Company'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 43 locations throughout 29 countries around the world, and has approximately 4,600 employees.