FGK Clinical Research is a European CRO, offering full service for conduct of clinical trials in all phases, specialized on biotech and medical device companies. Founded in 2002, owner-managed structure, guaranteeing a personal and flexible approach to our clients.  

FGK has the right size to handle international multi-center studies with hundreds of patients or single country studies with a few patients but is still small enough to guarantee a personal service to the sponsor. With our 240 highly qualified medical, scientific and regulatory experts, we have all knowledge and experience necessary to succeed in Europe and can guide you through the clinical trial process, from planning and approval to the final report.

Full service or partial services for conduct of clinical trials including:

* clinical trial management and clinical monitoring
* regulatory submissions
* biostatistics
* data management
* eSolutions
* medical writing
* medical safety
* quality assurance
* pharmacovigilance
* consulting services

FGK Pharmacovigilance GmbH offers vigilance services in support to pharmaceutical, biotech, medical device and cosmetics companies obligations in managing risk-benefit profile of their products.
Our services can be added to existing vigilance system of a client on a modular basis or comprise a stand-alone center of product vigilance on national, international or global level. 

FGK Representative Service meets legal requirements of sponsor companies that do not have a subsidiary within the European Union, Switzerland and the United Kingdom, for the purpose of performing clinical research projects in this region.
 

Services offered for clinical development in Europe:

• Legal Representative

• SME Status

• Orphan Drug Designation

• Marketing Authorisation