Professionelle Beratung für eine effiziente Produktentwicklung
Die klinische Entwicklung ohne unnötige Verzögerungen ist der Traum eines jeden Biotech- oder Pharmaunternehmens. FGK ist sich dessen bewusst und misst diesem zentralen Faktor höchste Bedeutung bei. Wir nehmen uns viel Zeit für die Vorplanung, denn nur so kann Ihr Projekt im Zeit- und Kostenrahmen ablaufen.
Viele unserer Mitarbeitenden haben in großen pharmazeutischen und kleinen biotechnologischen Unternehmen gearbeitet, und in allen Bereichen dazwischen. Wir sprechen Ihre Sprache und helfen Ihnen gerne bei allen klinischen, regulatorischen oder biostatistischen Fragen, die sich im Laufe der Produktentwicklung ergeben können.
Wir kennen die lokalen Besonderheiten fast aller europäischen Länder und sind in der Lage, Missverständnisse zu vermeiden, indem wir Tipps und Anregungen geben, an die Sie vielleicht nicht gedacht haben. Aus diesem Grund wird unser professioneller Rat von Kunden in aller Welt in Anspruch genommen, von denen wir viele bei der Entwicklung neuer medizinischer Geräte, Präparate, Arzneimittel und biotechnologischer Produkte unterstützt haben.
Wie wir unsere Kunden beraten
- Wir bieten biostatistische Unterstützung für die Entwicklung von Arzneimitteln und Medizinprodukten, Berechnung des Stichprobenumfangs, adaptive Designs, Modellierung klinischer Studien
- Wir beraten Sie zum Set-Up klinischer Studien, dem Studiendesign und klinischen Endpunkten
- Wir begleiten Sie bei der Planung von Zulassungsstrategien, der Evaluierung globaler Programme und der Risikobewertung
- Wir organisieren Treffen mit Opinion Leadern, Scientific Advice Meetings bei Zulassungsbehörden, Gremien zur Bewertung der Sicherheit anhand von Studiendaten (bestehend aus erfahrenen Statistikern, Ärzten und Toxikologen)
- Wir bewerten Produktentwicklungsstrategien und klinische Daten
How FGK can support
- Our clinical trial consulting approach focuses on extensive protocol development support with clear definitions of primary and secondary endpoints which are vital for regulatory approval.
- We advise on the best set-up of clinical trials, countries and study sites.
- Our team offers biostatistical support for drug and medical device development, including sample size calculations, clinical trial modeling and adaptive designs. They know the local differences in European regions and the US and help you avoid confusion through specific suggestions.
- We also supports in setting up meetings with opinion leaders and regulatory authorities (scientific advice meetings) to improve study designs before implementation. This early contact with regulatory bodies saves time and money by confirming what evidence they need upfront.
- In later stages, we organize the conduct of meetings with data safety boards (made up of skilled statisticians, clinicians and toxicologists).
Maintaining compliance without regulatory overload
Regulatory compliance doesn't need to be a burden. FGK spreads compliance work throughout the study instead of cramming it before inspections. This cuts last-minute rushes, extra costs, and stress.
FGK builds strong partnerships between study sites and project teams. These teams work together to handle regulatory needs quickly instead of blaming each other when problems come up .
Statistical analysis and interim reporting
Your trial might need strategic interim analyzes for key decisions. FGK's statistical experts create protocol-specified adaptive designs that keep study integrity intact while giving practical insights. These interim analyzes help decide about sample size changes, treatment arm updates, or early trial endings.
FGK balances getting enough information with keeping participant risk low. Our biostatisticians use proper alpha adjustments to maintain overall Type I error rates during multiple analyzes.
You can then make smart choices about your trials based on interim data.
Flexible service models: full or partial outsourcing
We shape our global clinical trial consulting to match your internal capabilities. You might need the complete management of your clinical program or support for specific functions and clinical phases. Some clients want full-service outsourcing. Others keep certain functions in-house. FGK reviews your product development strategies and clinical data. Then we align our support with your team structure. FGK’s flexible service models fits your requirements perfectly.
FGK’s consulting services across the trial lifecycle
We deliver custom clinical trial consulting in all development phases. You get exactly the support needed at a specific stage. We guide you through the development process with practical solutions that minimize delays — a key priority we take seriously.
Working with FGK: What clients can expect
Starting a partnership with FGK means you get transparency and client-focused, flexible service. While working together, FGK creates an environment based on trust, respect, and appreciation — values that directly shape how they work with clients.
Examples of successful biotech clinical trial consulting
Client testimonials show FGK's unique service quality:
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Christoph Ganss
Founder & CEO, Rheacell GmbH & Co. KG
"FGK's professionalism, flexibility, and deep expertise in clinical trials have consistently exceeded our expectations. Their team's ability to adapt quickly while maintaining the highest quality standards has been instrumental in the success of our Phase I/IIa and Phase IIb studies."
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Prof. Michael Hudecek
Chair of Cellular Immunotherapy from University Hospital Wuerzburg
"Since 2018, FGK has been an invaluable partner in our clinical early-phase CAR-T cell projects. Their extensive experience in advanced new therapies, like ATMP and cell therapy projects, has provided us with the expertise and support needed to navigate this complex field. Their commitment to high-quality research and their deep understanding of innovative therapies make them a trusted and essential partner in our development efforts. We look forward to continuing this successful collaboration."
Conclusion
Partnering for success: The FGK advantage
Every biotech and pharmaceutical company dreams of product development without delays. We know this well and make it the cornerstone of our consulting approach. FGK's dedication to proper planning cuts down the risk of extended timelines, budget issues, and regulatory hurdles that often derail development processes.
FGK brings a team that deeply understands both the science and practicality of drug and device development. Our experts offer complete support through all development phases and deliver solutions that match your product's specific needs.
We work as a natural extension of your organization, not just another vendor. On top of that, our grasp of local nuances helps dodge issues through smart suggestions you might have missed.
Expert consultation from day one makes all the difference in keeping schedules on track, cutting unnecessary costs, and getting reliable, high-quality data. FGK brings the expertise you need for success — from biostatistical support and study design to regulatory strategy and managing your entire clinical program.
You want to direct your path through the complex world of clinical trials with minimal risks and maximum efficiency? FGK Clinical Research Services is your experienced consulting partner for drug and device development success.
