FGK CRO: flexible experts and reliable solutions

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FGK is a full-service CRO with its headquarters in Munich, a branch office in Berlin, and subsidiaries in Czech Republic, Poland, and Hungary, specialising in collaboration with small- to medium-sized biotech, medical device, or pharmaceutical companies.
FGK Clinical Research’s philosophy is to prepare and conduct high-quality clinical studies in close interaction with its clients, throughout the project but also far beyond it, as maintaining a good relationship forms the basis of long-term cooperation.

For 20 years now, FGK has been managing clinical studies from Phase I to IV, and from planning to the final report. Phase II and III trials are the company’s main focus. FGK has experience in every important medical indications, including particular focuses in oncology, cardiology, neurology, dermatology, and gastroenterology.

Broad knowledge in ATMPs and rare diseases completes FGK’s expertise. Besides its services for drug development, FGK also helps to guide all kinds of innovative medical devices through the increasingly demanding framework of clinical investigations. At the same time, FGK is constantly expanding its expertise and keeping pace with the digitalisation of clinical studies.

The extensive experience of its 220 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 centralised 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 European study sites themselves. For additional countries and sites in the US/Canada, the company has suitable long-term partners.

Since 2017, FGK has participated in an independent ‘GCP Qualification Programme’, offering clients the possibility to obtain an all-encompassing audit report from a neutral third party.

FGK Clinical Research’s Services

• Drug and device development
• Biostatistical support

Regulatory Affairs
• Submission
• All communication with competent authorities and ethics committees

Project Management and Monitoring
• Development of study documents
• Study set-up and feasibility
• Investigator meetings
• Site management & monitoring
• TMF handling

Medical Safety
• Adverse event management and assessment/reporting
• Drug safety, medical monitoring and adverse event coding

Data Management/Biostatistics
• CRF design
• Data collection, review, and analysis

Medical Writing
• Generation and review of entire spectrum of regulatory documents

eSolutions for Clinical Trials
• In-house set-up of eCRF with integrated IWRS, eTMF, CTMS

Quality Assurance
• Regularly reviewed and updated set of SOPs
• Quality system audited on a regular basis
• Audits on behalf of sponsors
• Assistance during inspections

FGK Pharmacovigilance and FGK Representative Service enable FGK to offer its clients pharmacovigilance services, including qualified person responsible for pharmcovigilence (QPPV) and pharmacovigilance systems master file (PMSF) management services, as well as legal representation for non-European customers conducting clinical studies or seeking marketing authorisation within the EU/EEA.

Veröffentlicht: 03.02.2023