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
  • HTA trials

Including a broad range of clinical statistical services:

  • Statistical input into study protocols
  • Sample size / power 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
  • HTA Analysis (subpopulations, subgroups, heterogeneity tests)
  • Statistical exploratory analysis for publications, abstracts, and manuscripts

As well as statistical programming:

  • Analysis datasets
  • CDISC (SDTM and ADaM)
  • Tables, figures, listings
  • Production of SAS Macros
  • Statistical program validation
  • Confirming statistical tests and ad-hoc reports with SAS

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