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