Services

Study Planning

  • Aid in selection of study design, estimands and statistical analysis methodology

  • Estimate sample sizes and perform independent reviews

  • Write statistical sections of protocol

  • Provide input into CRF design

Statistical Analysis

  • Write or review Statistical Analysis Plans and Table, Figure & Listing (TFL) Shells
  • Write or review ADaM specifications
  • Program or validate ADaM Datasets and TFLs
  • Review TFLs and statistical analysis results
  • Act as Independent DMC Statistician
  • Perform Data (Quality) Reviews

Reporting of Results

  • Write statistical reports
  • Aid in Clinical Study Report writing
  • Co-author publications

Drug Submission Support

  • Interact with regulatory agencies
  • Write statistical sections of regulatory documents
  • Support integrated analyses

Process Optimization

  • Review or write Standard Operating Procedures (SOPs) and Working Instructions for Statistics processes
  • Review or create Statistics templates, standards, checklists or guidance documents

Statistical Training

  • Statistics for non-Statisticians
  • Introduction to Statistics in Clinical Drug Development
  • Sample Size Calculations
  • Estimands