Full-Service CRO for clinical trials (Phase I–IV) in pharma, biotechnology and medical devices.
FGK Clinical Research GmbH
Munich (HQ) · Berlin · Guildford, UK · Cambridge, MA, USA · Prague · Warsaw · Budapest · NetherlandsNew on Amplifa
About FGK Clinical Research
FGK Clinical Research GmbH is a European full-service contract research organization (CRO) headquartered in Munich. The company supports pharmaceutical, biotechnology and medical device companies in planning and conducting clinical trials in all phases (I–IV) and numerous therapeutic areas, including oncology, cardiology, neurology, rare diseases and cell therapies (ATMP). Its service portfolio includes clinical trial management, regulatory and ethics submissions, project management and site monitoring, data management and biostatistics, pharmacovigilance and safety reporting, medical writing, as well as quality assurance and audit support. In addition, the group offers the contractual representation service for sponsors in Europe (FGK Representative Service) and global pharmacovigilance (FGK Pharmacovigilance). With more than 230 employees in Germany, Poland, the Czech Republic, Hungary and – since the acquisition of Clinicology Ltd. in February 2024 – also in the United Kingdom, FGK manages national and international studies. Further locations exist in Cambridge (USA) and the Netherlands.
- Site
- München
- Processes
- Full-Service Clinical Trial Management (Phase I–IV), Regulatory and ethics committee submissions, Project management and site monitoring, Data management and biostatistics, Pharmacovigilance and safety reporting, Medical writing and scientific documentation, Quality assurance and audit support, Contractual representation of sponsors in Europe (FGK Representative Service)
- Materials
- Clinical Trial Management, Regulatory Affairs, Pharmacovigilance, Data Management & Biostatistics, Medical Writing
- Certificates
- ISO 14155 / EU MDR (study framework)
- Founded
- 2012
- Employees
- 230+
- Industries
- Pharma, Biotechnology, Medical Devices/Diagnostics
- 01
Study design and consulting
- 02
Regulatory and ethics submissions
- 03
Project management
- 04
Site monitoring
- 05
Data management and biostatistics
- 06
Pharmacovigilance and safety reporting
- 07
Medical writing and documentation
- 08
Quality assurance and audit support
Services and Expertise
Clinical Trial Management
Full-service management of clinical trials of all phases for pharma, biotechnology and medical devices.
Regulatory Affairs
Regulatory and ethics committee submissions in accordance with EU MDR, ISO 14155 and FDA guidelines.
Pharmacovigilance
Global pharmacovigilance and safety reporting across the group.
Data Management & Biostatistics
Data processing and statistical analysis of clinical trial data.
Medical Writing
Scientific documentation and study reports.
Locations
Munich
DEHeadquarters
- Materials
- All services
Berlin
DEBranch Office (project/site management, monitoring, QA Phase II–IV)
Guildford
GBUK subsidiary Clinicology – an FGK company (since 02/2024)
Cambridge, MA
USUS Office
Prague
CZFGK Clinical Research s.r.o. (Regulatory Affairs, PM, Monitoring Phase II–IV, CZ/SK)
Warsaw
PLFGK Clinical Research sp. z o.o. (Regulatory Affairs, PM, Monitoring)
Budapest
HUFGK Clinical Research Kft. (Regulatory Affairs, PM, Monitoring)
Amsterdam
NLLocal team for clinical trials in the Netherlands
Therapeutic Areas
Inside the production
Industries
Additional services
Quality
FGK provides quality assurance and audit support as well as studies under regulatory frameworks such as EU MDR, ISO 14155 and FDA guidelines.
| Evidence | Munich |
|---|---|
| ISO 14155 / EU MDR (study framework) |
History
- 2012
Foundation of Clinicology Ltd. (according to LinkedIn).
- 2024
FGK Clinical Research GmbH acquires Clinicology Ltd. (14.02.2024); continued as 'Clinicology – an FGK company'.