Book a free consultation with our experts or contact us at:
FGK is a full-service clinical research organization est. 2002, providing a complete range of clinical development and consulting services for small to mid-sized pharma, biotechnology and medical device companies. Dedicated expert teams ensure flexible and efficient clinical trial execution across Europe and US.
Clinical trials are one of the most demanding phases in the lifecycle of any pharmaceutical or biotechnology product. Sponsors face increasing regulatory pressure, rising costs and limited internal resources.
Many companies struggle with:
How we have your back:
Start your clinical trial with confidence.
As a European clinical contract research organization, FGK provides the complete range of clinical development services while remaining flexible enough to tailor support to your exact study requirements. We act as your clinical research contractor, delivering high-quality clinical trial services and regulatory expertise to accelerate your path to market.
We provide clinical trial services across a broad range of therapeutic areas, supporting innovative therapies, biologics, medical devices and advanced treatment approaches throughout all clinical phases.
We are experienced in
Our clinical research services are designed for
Small, highly motivated teams dedicated to your study goals, strengthened by a constantly low staff turnover.
Deep knowledge of EU clinical trial regulations and multinational studies from First-In-Human till Post Approval.
From consulting and regulatory strategy to trial execution and reporting.
Services customized to your exact development needs.
Senior Director Clinical Operations at FGK
Sponsors value our consultative, collaborative approach at eye level — this feedback motivates me every day. As a true extension of their team, my team and me work proactively, flexibly, and always focused on achieving their individual goals — far beyond simply completing tasks. When we work together with trust and shared purpose, genuine human connections emerge and strengthen over time.
Director General Management at FGK Hungarian office
Working in an owner-managed company where employees are given the feeling of working in a positive, open-minded environment is a great opportunity. Thanks to flat hierarchies and short decision-making paths, I can work consistently effectively.
Whether you need full clinical development services or support for specific trial processes, our experts are ready to help.
FGK conducts clinical trials across all phases, from phase I to IV for medicinal products, medical devices, and combination products.
We support multinational clinical trials throughout Europe and the US and coordinate all processes efficiently through our network of experienced study centers.
FGK offers clinical trial management and clinical monitoring, regulatory submissions, medical writing, biostatistics, data management, eSolutions, medical safety and consulting services – as full package or single services tailored to your needs.
We are experienced in all important inner medicine indications and with more than 650 studies accompanied since 2002, we have also gained broad experience in rare diseases, advanced therapies and pediatric indications, both with medicinal products and medical devices.
Yes, our Regulatory Affairs team guides you through the entire approval process, ensuring all country-specific regulatory requirements are met.
Absolutely – our project management and monitoring teams work closely with your internal team and take care of operational study management.
Yes. We deliver high-quality clinical data, statistical analyses, and ensure GCP-compliant processes for all study phases. We also provide internal state-of-the-art eSolutions so you have all parts of clinical data management handled at once.
As our staff turnover is constantly below or around 3%, experience stays with us for many years, ensuring a maximum consistency in the study team supporting your project.
Yes, we have a broad network of motivated and experienced study sites for a vast number of indications and can conduct a high-end feasibility to find the study sites with most promising recruitment potential.
Timing depends on the study and scope of services. Typically, we can start quickly after a short project kick-off phase thanks to our experienced teams and established processes.
