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Clinical research is a global issue: this does not mean, however, that clinical research is performed in the same way all over the world, as research can differ from country to country. This article will provide an overview of how to successfully conduct trials in co-operation with site management organisations (SMOs) in Germany.
The European Context
The term 'Europe' is usually perceived to represent a well-defined legal entity. This perception can erroneously lead to the idea that clinical trials are performed in more or less the same way in all of the European states. However, every country in Europe has its own legislation, regulatory issues, medical tradition and communication methods. Taken together they form a cocktail of clinical research behaviour that needs to be specifically understood and applied. Europeans are aware that each European country is different, but they often forget to point out the importance of this to non-Europeans. |
