Biostatistics from the Beginning: Developing a Statistical Analysis Plan The Statistical Analysis Plan (SAP) keeps the study team focused on achieving the same goals during the study and development process. Our Statistical Analysis Plan (SAP) services include CSR Statistical Analysis Plans, Interim Statistical Analysis Plans, Statistical Analysis Plans and Integrated (ISS, ISE) Statistical Analysis Plans. We will work with you to develop:
  • Primary and Secondary Objectives
  • Sample Size and Power Estimation
  • Randomization and Blinding of Sponsor Team
  • Global Definitions and Conventions, Analysis Windows
  • Rules for handling Missing Data
  • Definitions of Populations: Efficacy-evaluable, Intention-to-Treat (ITT), Safety and other sub-groups
  • Interim Statistical Analysis
  • Demographics and Baseline Characteristics
  • Subject Disposition and Compliance to Study Treatment
  • Method for Analysis of Efficacy Endpoints
  • Evaluation of Safety Parameters