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SMOs in Germany - Conducting Quality Clinical Trials

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.


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By Franзois Geelen, General Manager at Geelen & Geelen GmbH

Francois Geelen is General Manager of Geelen & Geelen GmbH, an employment consultancy specialising in clinical research, and publisher of the DZKF, a clinical research magazine in Germany. Internationally recognised, Francois Geelen regularly gives lectures and has written publications on clinical research, using his leadership experience in professional organisations. He is also a past President of the Association of Clinical Research Professionals (ACRP) and has served as a global board member for many years.

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Francois Geelen
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