PAREXEL OFFERS PROACTIVE APPROACH TO DRUG SAFETY AND RISK MANAGEMENT WITH PHARMACOVIGILANCE SERVICES
BOSTON, MA June 14, 2007 - PAREXEL International Corporation (NASDAQ: PRXL), a leading global bio/pharmaceutical services organization, is helping its customers take a proactive approach to drug safety and risk management with its Pharmacovigilance Services. Bio/pharmaceutical companies work with PAREXEL’s Pharmacovigilance Services to incorporate safety considerations and risk management into their drug development programs -- from the earliest stages where the most potential for benefit exists, through the entire development lifecycle.
“Bio/pharmaceutical companies today find themselves under escalating public scrutiny with respect to drug safety issues,” says Mark A. Goldberg, M.D., President of Clinical Research Services and Perceptive Informatics, PAREXEL International. “Coupling that with the growing number of regulations and risk management commitments, and companies are facing a dramatic drug safety issue that can’t be ignored.”
Through PAREXEL’s Pharmacovigilance Services customers have access to a global network of experts that can help weave the appropriate safety and risk management measures throughout the entire drug development process. These experts include safety physicians, scientists, and pharmacoepidemiologists as well as consultants that bring regulatory experience from leading Health Authorities, such as the FDA or the MHRA. Services include adverse event management, regulatory reporting, design and maintenance of global safety databases, coding, trend analysis, and risk management. The program continues across all phases of clinical development through launch and post-marketing surveillance. If desired, companies can effectively outsource their entire drug safety departments to PAREXEL.
“For a pharmacovigilance program to work, bio/pharmaceutical companies must lay a foundation of safety risk early on and manage it closely throughout the entire drug lifecycle,” says Uwe Maennl, M.D., Ph.D., Vice President and Head, Pharmacovigilance Services, PAREXEL. “PAREXEL has focused significant effort on developing a comprehensive pharmacovigilance offering to help these companies reduce potential costly setbacks that can threaten both product revenues and reputation.”
For more information, visit www.PAREXEL.com or visit us at the DIA 43rd Annual Meeting, booth #724.