Beratung für Ihre klinische Studie

Clinical trial consulting reduces the risk of delays that can get pricey in biotech, medtech and pharmaceutical product development. Every small to mid-sized company knows the pain of extended timelines, budget issues, and regulatory hurdles that can stop even the most promising drug or device. Sponsor companies dream of smooth clinical development without delays - and FGK understands this key point.

Our detailed global clinical trial consulting service covers everything — from biostatistical support and study design to regulatory planning and hands-on experience in Europe and the US, for giving your trial the best starting conditions. Your study is more likely to stay on schedule and within budget by taking into account all local differences in study regions. Consultancy by an experienced CRO helps you avoid mix-ups through specific recommendations.

Why early planning matters

Smart planning lays the groundwork for successful clinical trials. Research proves that good planning, starting in pre-clinical stages, can significantly reduce overall development costs by preventing late-stage changes. Better planning helps products reach the market faster through better submission preparation.

Common pitfalls when rushing into a clinical trial

Clinical trials without proper planning run into several roadblocks that can derail even the most promising treatments:

1. Overly complicated protocols with too many eligibility criteria make patient recruitment hard.
2. Not properly thought-through analyzes can ruin the results of a well-designed clinical trial
3. Poor site selection causes recruitment failures when staff doesn't believe in the product's potential
4. …

Many companies wait to pick vendors until after they finalize protocol design — which can already be too late for the best implementation.

• 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.

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:

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.

Get in touch today!