Europe, home to approximately 7% of the global population, is an attractive location for clinical trials because of its well-developed medical systems, high clinical standards, and universal access to health care and prescription drugs. As a result approximately 20% of the world’s clinical trials are conducted in Europe, which is defined in this context as the 30 countries that contribute to the European Medicines Agency (EMA): all 27 European Union (EU) member states and 3 countries (Iceland, Liechtenstein, and Norway) that are part of the European Economic Area/European Free Trade Association (EEA-EFTA).
Compared with single countries, such as the US or Japan, the confederation of separate nations that comprise Europe can present both challenges and opportunities for clinical trials at any stage of drug development. To optimize results, many pharmaceutical or biotechnology companies expanding into Europe elect to partner with contract research organizations (CROs). There are numerous options, and this paper reviews three key areas to consider when choosing a CRO partner:
- Experience with European regulatory authorities
- Experience with European key opinion leaders
- Experience “on the ground” in Europe
Experience with European Regulatory Authorities
The ideal CRO partner has extensive experience with the national competent (regulatory) authorities of several individual countries. The choice of country can have a significant impact on the success of a drug development program. The national competent authorities approve clinical trials performed within their country, and there can be considerable differences between the agencies in expertise, staff, funding, and risk tolerance. I recommend considering two key questions when selecting which country/countries to approach with a clinical development program.