Biostatistical Services

We bring a deep understanding of the science of diseases and compounds

Biostatistical Services

We bring a deep understanding of the science of diseases and compounds

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 expertise and backgrounds to provide a constructive and client-oriented statistical assistance.

Our Statistical Services include:

  • 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
Corporate Vision MagazineAward Winner

Exom is proud to announce that Corporate Vision Magazine has awarded us the 2021 Corporate Excellence Award as "Most innovative Full-Service CRO" for our technology-driven approach to clinical trial management.

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