BIOSTATISTICS

Exom Group offers full services for the design and methodology within clinical trials. We bring a deep understanding of the science of disease and compounds, as well as different expertises and backgrounds to provide a constructive and client-oriented statistical assistance.

OUR SERVICES

  • Study design, analysis and endpoint strategies
  • Sample size determination or power considerations on trial design using adequate software programs
  • Generation of randomization lists for simple and special designs
  • Planning and performance of statistical interim analyses, interpretation of results and advice for further conduct of the clinical trial
  • Preparation of comprehensive Statistical Analysis Plans (SAP) according to international rules and regulations
  • Preparation and conduct of Blinded Data Review Meetings and summaries of results, provision of final allocation to analysis populations based on automatic assignment
  • Analysis strategies that are International Conference on Harmonization (ICH)-compliant
  • Production of audit-ready tables, listings and figures
  • Delivery of data in Clinical Data Interchange Standards Consortium (CDISC) format
  • Reporting and presentation of results, interpretation from the statistical perspective and supporting conclusions
  • Integration of the randomization scheme with Interactive Web Randomization (IWR) systems
  • Meta-analyses, overall evaluations for efficacy or safety endpoints, use of fixed and random models, adequate graphical presentation
  • Safety dossiers, overall safety summaries taking into account different trial settings and coding
  • Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results and to prepare manuscripts and abstracts
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