FGK’s Clinical Trial Biostatistics

Biostatistics are applied in fields such as clinical trials, epidemiology, population genetics, and more. In clinical research, they are critical for the analysis, presentation and interpretation of medical data and enable researchers to make informed decisions on the efficacy and safety of a drug or treatment. Clinical trial biostatistics are an integral part of the entire drug development process, from trial design to protocol development, sample size calculation, safety monitoring up to analysis. Biostatistics also help to present a complex set of medical data in renowned scientific journals. 

At FGK, we understand the critical role that statistical analysis plays in the success of medical research. Our commitment to high-quality statistical services ensures you are supported throughout each project phase. Our biostatisticians bring broad professional experience to your trial conduct. They are trained in state-of-the-art statistical methodologies and have expertise in designing and analyzing clinical trials, observational studies, and other medical research projects. With a team of highly skilled biostatisticians and programmers, we offer a wide range of services tailored to meet your unique needs.

We support you in choosing the right study design (incl. adaptive designs), calculate the suitable sample size, and develop the randomization strategy (if applicable). Afterwards, we prepare the statistical analysis plan in close cooperation with you, apply the appropriate statistical methods and deliver high-quality results – not only for any kind of interim and final analysis but also for data safety monitoring boards, dose escalation committees, or any other data monitoring committee.

We are committed to delivering high-quality statistical services and support you at any stage of your research project.

• Statistical Consulting: We provide expert guidance throughout your research process. Our biostatisticians offer a wide range of expertise to support you at any stage of your research project with statistical insight.
• Study design and protocol: In collaboration with you and other experts, we choose the right study design (incl. adaptive designs), calculate the suitable sample size and support in the development of study protocols including estimands concept.
• Randomization: We develop elaborate trial specific randomization plans and randomization lists.
• Data Monitoring: Our extensive statistical support assists your data safety monitoring boards, dose escalation committees, and any other data monitoring committee.
• Statistical Analysis: Our biostatisticians employ advanced statistical techniques to analyze all data collected. We prepare comprehensive statistical analysis plans describing all details of the statistical methods to be applied. Based on them we do statistical modeling and programming (incl. ADaM) and provide meaningful tables, listings, and graphs for all planned analyses to support evidence-based decision-making.
• (Blind) Data Review Meetings: We prepare and conduct (blind) data review meetings to take all steps necessary before database lock and statistical analysis (as check of data quality, assignment of patients to the analysis sets, handling of data/analysis issues, …).
• Clinical study report: We assist in the interpretation of the analysis results and write or review statistical sections of clinical study reports.

Regulatory bodies, such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency), require clinical trials to be designed, conducted and analyzed in compliance with stringent requirements. Biostatistics play a key role in ensuring compliance with these regulatory guidelines. Some regulatory agencies prefer data to be submitted according to the CDISC standards. FGK`s Biostatisticians ensure that the clinical trial data are mapped and formatted in compliance with CDISC ADaM standards, facilitating regulatory review and analysis. This standardized approach enhances data integrity, comparability, and regulatory compliance.