Clinical trials in Germany

Germany has many advantages for conducting clinical studies:

• It has one of the most advanced markets for clinical research.
• Full compliance to the international standards of ICH GCP (Good Clinical Practice).
• Perfect local regulations and compliance with international requirements.
• Leader of the European TOP-10 countries for registered clinical studies in 2016 (according to ClinicalTrials.gov¹).
• The study of the results of regulatory inspections, conducted by EU and US regulator representatives as well, shows a significantly lower percent of critical findings compared to other regions. In the period from 1995 to 2017, 45% of clinical trials in Germany did not have any objections of the FDA. The number is calculated from the ratio of NAI (No Action Indicated)² to the number of FDA inspection³.
• Time period for issuing of the clinical trial permit is 60 business days.
• Germany mitigated bureaucratic hurdles, which assured effective and fast cooperation with the regulator in the process of clinical trials.
• Fast European logistics.
• Professional CRO staff gained its experience on Germany’s longstanding clinical research market.
• Utilization of electronic clinical records or electronic medical cards significantly speeds up the process. It is especially important for the phase IV (post marketing).
• Availability of the leading experts and qualified and experienced investigators guarantees high-quality approach to conduct of clinical trials.