Statistics Services at bioskin

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 to IV)
  • Development of statistical parts of protocols
  • Power analyses and sample size calculations
  • Randomization services
  • Statistical Analysis Plan (SAP) development
  • Generation of table shells
  • Statistical analyses including interim analyses
  • Blind data review
  • Statistical programming (SAS)
  • Statistical reporting (integrated into study report or stand-alone statistical report)
  • High quality output of tables, listings and figures
  • Support to Medical Writing
  • Support for presentations or scientific publications
  • Analysis Data Model (ADaM) as per FDA recommendation

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

CDISC Gold Member