Services
Statistics
Based on our fundamental knowledge and the experience of our statistic experts, we offer statistical consultancy, planning, analysis and reporting for clinical trials.
Statistical Consultancy / Planning
- Development of the trial outline
- Adequate choice of the trial design including e. g. options of group sequential or adaptive designs
- Formulation of trial endpoints
- Formulation of suitable hypotheses for addressing the trial objectives (e. g. superiority, non-inferiority, equivalence)
- Adequate choice of significance level(s) and power incl. adjustments in case of interim analyses or multiplicity
- Provision of reliable sample size estimates
- Writing the statistical section of the trial protocol
- Generation of the statistical analysis plan
Example for optimization a study design concept concerning time and cost effectiveness by combining phase II (dose finding) and phase III (confirming efficacy)
Data Monitoring and Safety Boards (DSMB)
- Preparation of statistical tables and figures for DSMB sessions
- Participation as statistical expert in Data Monitoring and Safety Boards
Statistical Analysis & Reporting
- Programming of analysis files
- Programming statistical tables and graphs using SAS®
- Performance of statistical analyses
- Programme validation
- Generation of a statistical trial report
- Statistical contribution to clinical trial report
- CDISC / ADaM competence
- CDISC / FDA conform data export
Example: Calculation of the area over the curve (AOC) with and without intervention using SAS®
We would be happy to answer your questions about our services personally.