Biostatistics

The study that costs the most is the one that fails to achieve its goal. Errors in planning can jeopardize the study right from the start. We understand this well, and will make sure to set your study up for success from the very

Andreas Beust, Head of Biostatistics
We know that starting a trial can seem like an overwhelming task. As a Sponsor, you need to devise a precise plan that supports the objective of the trial, and ideally also aligns with the desired marketing claims. Thorough planning is required, and fundamental issues in the planning can jeopardize the statistical evaluation. Therefore, our specialist will gladly guide you through this process, provide input and help set up the trial for success from the very beginning.
We have the know-how to ensure that regulatory requirements are met, and that the trial interpretation supports your objectives and marketing claims. Every trial is unique, and we will make sure that your unique challenges are met with our expertise. Let us help your vision become a reality.

Trial Planning

Our Biostatisticians are involved right from the beginning of your study, to ensure that not only the sample size, but also the hypotheses and objectives, definition of analyses sets and statistical models to be used, as well as the specified trial design, ensure the highest degree of confidence in your desired outcome right from the onset of planning.

We also know how much trials benefit from a well thought-through database setup and from providing statistical input to the risk evaluation of the trial, to ensure all risks to the trial evaluation are well understood monitored from the beginning.

Continuous Oversight

During your study, our Biostatisticians ensure that data is monitored centrally to identify outliers and systematic errors and enable corrective and preventive actions before data integrity is at risk. Assistance in determining the impact of decisions made during your study on the evaluation is further provided, to ensure that all collected data can be evaluated as expected. A final data review prior to the analysis further ensures that all pre-specified analyses can be conducted as desired, and necessary changes are prospectively implemented.

Trial Evaluation

The final analysis of your study and the interpretation thereof are guided by our experts. To ensure that the analysis is tailored to your needs, we prospectively visualize all analyses, which helps speed up the time from database close to having the finalized results. We further see the benefit of using our Biostatisticians to help write the Clinical Study Report, ensuring that the interpretation of the results match your vision and are supported by the data.

Our Services

Whether you are developing a novel medicinal product, would like to expand the indication of your already available drug or aim to get a CE certification for your medical device: We are experienced and ready to support you in your endeavours. We can provide our expertise to you during different phases of your trial or throughout the whole study preparation and conduct.

Our services include:

  • Pre-trial planning
  • Feasibility support
  • Statistical consulting

Support in study protocol development

  • Trial design
  • Sample size calculation (supported via nQuery)
  • Description of hypotheses and estimands
  • Definition of analysis sets and subgroups
  • Support and preparation of randomization and blinding
  • Setup of expert committees, planning of DSMB meetings
  • Centralized Statistical Monitoring
  • DSMB meetings, Data Review Meetings
  • Interim Analyses
  • Sample Size Re-estimation
  • Preparation of Statistical Analysis Plan
  • Preparation of mock Tables / Figures / Listings
  • Complete study analysis
  • Preparation of Statistical Report
  • Support for Clinical Study Report
  • Post-hoc Analyses
Whether you are developing a novel medicinal product, would like to expand the indication of your already available drug or aim to get a CE certification for your medical device: We are experienced and ready to support you in your endeavours. We can provide our expertise to you during different phases of your trial or throughout the whole study preparation and conduct.