FGK Clinical Research GmbH

FGK is a full-service CRO based in Germany, with its headquarters in Munich, a branch office in Berlin, and subsidiaries in Czech Republic, Poland, Hungary, the UK and the US, specializing in collaboration with biotech, medical device, or pharmaceutical companies.

For 23 years, FGK has been managing clinical studies from Phase I to IV, from planning to final report. FGK has experience in all major medical indications, e.g. oncology, cardiology, neurology, dermatology, and gastroenterology Comprehensive knowledge in the field of ATMPs and rare diseases rounds off FGK's expertise. In addition to its services for drug development, FGK also supports all types of innovative medical devices in meeting the increasingly demanding conditions for clinical investigations. FGK is constantly expanding its expertise and keeping pace with the digitalization of clinical studies. The extensive experience of its 240 employees, who form an interdisciplinary, organically grown team of highly qualified medical, scientific, and regulatory experts, in addition to a stable, owner-managed company structure with flat hierarchies, enable FGK to skillfully execute even the most complex projects competently, flexibly, and personally.  Timely approvals and efficient troubleshooting are achieved through a combination of centralized project management and local monitoring, as well as local expertise in regulatory submissions within the country of study conduct. FGK’s in-house CRAs monitor many study sites themselves.

FGK also provides local sponsor representation services to international sponsors who want to conduct clinical trials in the EU, UK or Switzerland and can represent for all applications in drug marketing authorizations, orphan drug designations and obtaining SME status in Europe. And, FGK also provides pharmacovigilance solutions.  

Website: fgk-group.com