Clinical Research Consulting Services

Product development without any unnecessary delays is the dream of every biotech or pharmaceutical company. FGK is well aware of that and considers this central factor with utmost importance. We spend long enough time on pre-planning stages; only then will your project run on time and on budget.

Many of our personnel have worked in large pharmaceutical, small biotech companies, and everything in between. We speak your language and are very eager to help you with any clinical, regulatory, or biostatistical issue that may arise in the course of product development.

We know the local peculiarities of almost all European regions and are able to avoid misunderstandings by providing tips and suggestions that might not have occurred to you. This is why our professional advice is sought by clients worldwide, many of whom we helped co-develop new medical devices, compounds, drugs and biotech products.

How we advise our clients

• We provide biostatistical support for drug and medical device development, sample size calculations, adaptive designs, clinical trial modeling
• We advise on the set-up of clinical trials, study designs, clinical endpoints
• We guide you through regulatory strategy planning, global program evaluation, risk assessment
• We organize opinion leader meeting, scientific advice meetings at regulatory authorities, data safety boards (made up of skilled statisticians, clinicians and toxicologists)
• We evaluate product development strategies, clinical data