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Biostatistics

We offer a wide range of specialized biostatistical services to manage all aspects of your study from design to data analysis.

Cost-effective study design and meaningful data by well-designed and thoroughly analyzed studies.

We help you design and power your study to become statistically meaningful and cost-effective. Our profound understanding of clinical trials and our advanced statistical methodology ensures results that are scientifically accurate, validated and reproducible.

Our Services

  • Protocol development support
  • Sample size calculation
  • Statistical Analysis Plan (SAP) development including specifications for tables/listings/figures (TLFs)
  • Support in the randomization set-up
  • Data screening including outlier treatment and data imputations
  • Interim analyses
  • Statistical programming with SAS®
  • Validation of all SAS-scripts including double programming
  • Statistical reports
  • ADaM and define.xml
  • Transfer of analysis data
  • Support in the interpretation of statistical results
  • Customized plots and analyses for publications
  • Data archiving

Special Features

  • Analysis of metabolomics data
  • Calculation of complex endpoints, e.g. endogenous glucose production

Services

Bioanalysis

We analyze low volume samples from all biological matrices to determine PK/PD profiles and to support your biomarker research.

Bioequivalence testing

Fast and efficient PK based bioequivalence testing of topical generics.

Clinical Studies

In-vivo clinical assessment of intradermal PK/PD profiles in healthy and disease subjects.
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