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The future for clinical research in Western Europe remains promising. European physicians are among the finest in the world, and their delivery of health care is first rate. While the region may not benefit from its eastern counterpart cost advantages, there are several attractive points to conducting research in this region.
The Western European clinical research landscape changed with the adoption of the European Union (EU) Clinical Trials Directive in 2004, which raised the standards of clinical research by simplifying the trial application process and providing a common set of regulations for member states. This has made the European pharmaceutical industry more competitive by streamlining the trial application process and harmonizing it across member states. It has also aimed to improve the quality and safety of clinical trials by allowing greater scrutiny of methodology and more stringent monitoring of adverse drug reactions.
Qualified and experienced investigators and research centers, as well as linguistic and cultural similarities with the US, are additional factors that support Western Europe's continued importance in clinical research.
It has been a long tradition that manufacturers wishing to sell a medical device to first conduct clinical studies in Europe to obtain a CE mark before conducting clinical studies in the United States to obtain FDA clearance.
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