Statistics

At bioskin^® our statisticians are involved in a project from the earliest stages of clinical trial planning.  They have a comprehensive understanding of the sponsor’s goal and study objectives, information which is essential to determining the ideal methods for collecting and analyzing your data.  Data presentations are optimized according to the client’s requirements.

Statistical services are offered as stand-alone services for dermatological and other therapeutic areas as well as part of full packages and include:

• Statistical consultation on study design
  (superiority, non-inferiority, equivalence trials, phases I, II, III, IV)
• Protocol development and statistical design
• Sample size calculations, power analyses
• CRF consultation (e. g. adherence to trial protocol)
• Randomization services
• Statistical Analysis Plan (SAP) development, generation of table shells
• Statistical analyses including interim analyses
• Statistical programming (validated SAS and nQuery Advisor installations)
• Blind data review
• Statistical reporting (integrated into study report or stand-alone statistical report)
• High quality output of tables, listings and figures (ASCII, SAS ODS)
• Support for presentations or scientific publications
• Electronic data transfer (also customized formats)

All services can be offered according to bioskin^® or sponsor SOPs.