Quintiles Names Head of iGuard Drug Safety Service
Prior to his appointment as president of iGuard, Stephenson had beenSenior Vice President of Quintiles' Strategic Research and Safety services, aposition he held since joining the company in 2003. Stephenson was thefounder of Health Research Solutions, an Australian strategic research serviceprovider acquired by Quintiles in 2002. He has a particular interest instrategic epidemiology and risk management, and he works closely with seniorindustry strategists to promote the use of strategic research activities tosupport advances in pharmaceutical research.
He is the author of Strategic Research: A Practical Handbook for PhaseIIIB and Phase IV Clinical Studies, and has written and co-authored manyarticles. He holds degrees in medicine and surgery from the University ofMelbourne.
iGuard offers patients and physicians access to timely, personalized drugsafety ratings and alerts. To receive the personalized alerts, patientsenroll in iGuard through the Web site, http://www.iguard.org, and follow asimple series of steps to become part of a membership network. Patientscreate a secure personalized iGuard profile that includes questions abouttheir demographics, medications and conditions which could impact their drugrisks.
"We're capitalizing on Hugo's expertise in the area of risk management andthe demand for consumer involvement in monitoring the safety of drugs that areon the market," said Dr. DeCherney.
The current U.S. drug safety monitoring system relies on physicians tovoluntarily report any serious drug reactions. Physicians are expected toidentify "signals" that a medication might be causing adverse events.However, it is estimated that only a small percentage of physicians filereports to the U.S. Food and Drug Administration's postmarketing surveillanceprogram, known as MedWatch. An FDA analysis found that pharmacists andconsumers each filed more MedWatch reports than did physicians in 2004.
With iGuard, if a serious side effect is suspected based on theinformation provided by the patient, iGuard sends an FDA MedWatch form to thepatient which they are instructed to give to their physician. In this way,iGuard empowers the patient to signal when a suspected adverse event occurs.
"iGuard will serve as a conduit for communication about drug safety," saidStephenson. "I believe that iGuard will contribute to improving our systemsfor gathering and disseminating information about drugs consumers are takingdaily."
iGuard is fastest and easiest way for patients to get information andsafety updates on the drugs they are taking. This drug safety monitoringprogram facilitates bi-directional exchange of timely and relevantinformation, enabling patients to take an active role in managing theirhealth. iGuard maintains an efficient communication channel where patientsand health professionals can monitor, evaluate and share information aboutdrug risks and benefits. Registration is free online athttp://www.iguard.org.
Quintiles Transnational Corp. is powering the next generation ofhealthcare by providing a broad range of professional services in drugdevelopment, financial partnering and commercialization for the biotechnologyand healthcare industries. With 19,000 employees and offices in more than 50countries, it is focused on providing customer-centric solutions that are thegold standard of the indus
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