Deeper insights

Smarter decisions

A biostatician's hand holds a stylus over a screen displaying clinical trial data.

Powering biostatistics to drive your study success

Beaufort’s team of biostatistics experts turns your data into powerful insights. We leverage a deep understanding of regulatory agency requirements and apply sound statistical principles to provide timely, accurate, and actionable analyses and reporting. Our knowledge and expertise in bridging data collection and statistical analysis enable us to provide the supporting evidence necessary for a successful regulatory submission.

Regardless of where you are in the planning and execution of your trial, our team can provide scalable solutions to meet the exact biostatistical needs of your project. Beaufort provides strategic consulting, statistics, and statistical programming as a standalone service, or bundled with comprehensive clinical research, regulatory consulting, and data management.

Statistical Consulting and Programming

Statistical Consulting

  • Study design development
  • Sample size estimation and power calculation
  • Protocol development and review
  • Statistical methodology recommendations
  • Analytical study design and analysis
  • Participation in regulatory agency meetings

Statistics and Statistical Programming

  • Statistical analysis plan (SAP) development
  • Randomization development
  • Programming and validation of analysis datasets, tables, figures, and listings
  • Interim and final analysis planning and reporting
  • Preparation of interim analyses and reporting for submission to data monitoring committees (DMC)
  • Clinical study report (CSR) preparation

Extensive Study Experience

  • Precision/Reproducibility
  • Linearity/Reportable range
  • Specimen stability
  • Reagent stability
  • Analytical sensitivity
  • Analytical specificity (interference)
  • Specimen storage
  • Carry-over/Cross-contamination
  • Assay cut-off
  • Reference Interval
  • Matrix comparison

  • Clinical comparison/Performance studies for qualitative assays
  • Method comparison for quantitative assays
  • Establishment of algorithms/Cutoffs
  • Companion diagnostic bridging studies
  • Antimicrobial susceptibility test (AST) systems