Statistics

Statistics are a crucial aspect of clinical trials. As stated in the ICH GCP E9 Guideline:

 “The actual responsibility for all statistical work associated with clinical trials will lie with an appropriately qualified and experienced statistician, as also indicated in ICH E6.”

Therefore every individual in our biostatistician team not only holds a high academic degree (M.Sc. or PhD) but they are also certificated on ICH Good Clinical Practice training.

Our biostatistician team would be happy to support you in all statistical aspects of your project during the planning and conducting of a trial. We offer high quality services that can be specifically adapted to any project. Our biostatisticians have experience in different trials including drug development studies, medical device studies and non-interventional studies. Our service includes but is not limited to:

  • Trial design consulting (traditional design, crossover design, adaptive design)
  • Support in study protocol development
  • Sample size calculation
  • Randomization by using our QCTMS IRT Tool
  • Preparation of statistical plans
  • Interim analyses
  • Support during the conduct of a study (especially in studies with an adaptive design)
  • Performing Study analyses
  • Preparation of final statistical reports

Each task is performed in accordance to the ICH GCP E9 Guideline as well as our own SOPs or those of our Client. We pay special attention to transparency and a close contact with the project team.

Benefit from both our Data Management and Statistics services: Having both services under one roof offers you many advantages:

  • Less costly
  • Easy and secure data transfer
  • Our analysis starts right after data base lock
  • No problems with different software or software version
  • No export and import problems

Don’t hesitate to call us if you have any questions or comments as to how we can help you!