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New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development
Date:6/18/2009

to find better tools and novel approaches to implement the requirements of regulations efficiently and cost effectively," says Dr. Suzanne Gagnon, Chief Medical Officer, ICON Clinical Research.

The report was commissioned by ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, and developed by IMS Health, the world's leading provider of market intelligence to the pharmaceutical and healthcare industries.

Phase IV activities, including observational trials or "safety registries" that gather data on the use and effectiveness of medications in the real world are expected to be particularly impacted by new regulations, according to the survey. Eighty percent of respondents anticipate the number of Phase IV trials to grow over the next five years, while 58 percent indicated that safety registries increasingly will be used to monitor drug safety at every stage of the clinical trial process.

"The move toward greater transparency around drug safety remains a regulatory and political priority worldwide," says Nigel Burrows, Senior Principal, Management Consulting, IMS. "The pharmaceutical industry has and continues to respond to this challenge, both in drug clinical development and commercialisation. These efforts have the potential to go beyond simply satisfying regulatory requirements, leading to more clinically effective and commercially viable advances that improve outcomes and set new standards of care."

Notes to editors

Survey methodology

ICON commissioned IMS Health to conduct a survey that explored global trends in drug safety issues, and to evaluate the impact of recent safety regulations on the industry. A total of 140 people were questioned via a telephone interview, and included the heads of pharmacovigilance, safety and clinical research functions among pharmaceutical and biotechn
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SOURCE ICON plc
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