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.
Smooth Drug Development provides consulting services in the field of clinical research to pharmaceutical and biotech industries in Germany, Latvia, Lithuania, Estonia, Hungary, Slovakia, Croatia, Russia, Ukraine and Belarus.
1The base is available at here.
2More information regarding the deficiency classification you can find at here.
3More information regarding the amount of conducted FDA inspections you can find at here.