Study design

The design justifies the study

A study design that has been created correctly forms the major basis of the overall project.

We attach importance to an individual concept, which meets the requirements of our clients and those of the official bodies.
Needless to say, we conform to international standards.

Statistical consultancy and planning

  • Developing the specific question
  • Defining the scope of the study / sample size planning
  • Implementing the question in an adequate study design (synopsis, protocol)
  • Defining appropriate measurement techniques and instruments (validity and reliability)

Statistical analysis

  • Creating the statistical analysis plan (SAP)
  • Statistical processing of data
  • Side effect screening

Statistical reports

  • Biometric report
  • Statistical part of the integrated report according to ICH
  • Statistical part of NIS (PASS) reports
  • Publications