Biometrics

Biometrics forms a solid basis for the successful planning and implementation of a clinical study. Both the conception and methodology of the study and the statistical and clinical assessment of the collected data require experience in order for the study to meet the authorities' high quality standards for licensing purposes or publications, thereby leading to success.

Study preparation

  • All study phases I-IV
  • Statistical consultancy and planning according to international standards (incl. FDA CFR Part 11) and the indication / question
  • Calculating sample size
  • Randomisation (creating randomised lists / emergency codes)

Statistical analysis

  • Statistical analysis plan (SAP)
  • Use of validated programming systems (SAS)
  • Statistical processing of data according to requirements or based on Pharmalog standards (tables, listings)
  • Statistical analysis with SAS according to international standards

Report

  • Biometric report
  • Non-interventional investigation consultancy / design, implementation (paper / electronic)