study design

PK/PD modelling & simulation, NCA & STATISTICAL CONSULTing

 

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Support with study design, sample size, dose-selection, choice of endpoint(s), interim analysis, DMC support & effective study data integration and evaluation

  • Quantitative & pragmatic approach to protocol development, study design, study endpoint(s), population & sample size
  • Study and literature data integration
  • Population PD modelling and clinical trial simulation
  • Quantification of the competitor landscape
  • Steering Committee, DSMB & DMC support