Statistical analysis and reporting
Are you conducting or planning a clinical trial or health economics study? Do you need help in planning and applying your statistical analysis? At Signifikans we have more than a decade of experience and we are happy to help.
All services are fully compliant with ICH E6 (Guideline for Good Clinical Practice) and ICH E9 (Statistical Principles for Clinical Trials).
- Statistical analysis of effect and safety
- Statistical analysis of health economic data
- Statistics and health economics rapport
- Tables, figures and listing of all data
- Effective presentations
- FDA submission preparation
- Input to study protocol
- Choice of study design
- Calculation of sample size
- Randomization (including safety envelopes)
- Data handling plan
- Statistical analysis plan
- Health economic analysis plan
... Additional services
Analysis and reporting
- Statistical analysis of retrospective data
- Meta analysis
- Data mining
- Factor analysis
- Principal component analysis (PCA)
- Independent component analysis (ICA)
- Teaching statistics
- Web-based eCRF
- Paper-based CRF or questionnaires.
- Hosting of eCRF
- Data entry (on site or in-house).
- Data validation
- Follow-up on data errors
- Database closure
- Perform group sequential design.
- Data monitoring committee (DMC).