Statistical analysis

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).

SERVICE overview

TRIAL Planning

  • 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

TRIAL conduct

  • 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).