Abstract
In 1979 Bristol-Myers Company began conducting investigative audits into non-US trials in an effort to assess the quality, scientific merit, and utility of these studies. Since then, they have conducted approximately 140 on-site clinical audits in 20 countries on 4 continents, and have encountered a great variety of different regulations, languages, customs, and problems. In 1985, an additional European-based audit group was established. Currently, Bristol-Myers Company audits non-US studies with both United States and European audit personnel using the same methodology and a mix of auditing teams.
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