Services

I offer statistical support for clinical research / development phase and “post-marketing” phase:

  • Phase I-IV clinical trials
  • NIS / PASS studies
  • Thorough QT / QTc trials

 

Including a broad range of clinical statistical services:

  • Statistical input into study protocols
  • Sample size calculation
  • Statistical analysis plan (SAP)
  • Preparation of TFL (tables, figures, listings) shell for clinical trial reports according to ICH guidelines
  • Statistical analysis interpretation
  • Pharmocokinetics (PK) / Pharmacodynamics (PD) analysis
  • Interim analysis
  • Meta-analysis
  • Statistical exploratory analysis for publications, abstracts, and manuscripts

 

 

As well as statistical programming:

  • Analysis datasets
  • CDISC (SDTM and ADaM)
  • Tables, figures, listings
  • Statistical program validation