Biostatistics

Beaufort’s team of biostatistics experts know how to turn your data into powerful insights. We leverage a deep understanding of regulatory agency requirements and apply sound statistical principals to provide timely, accurate, and actionable analyses and reporting. Our vast knowledge and experience in bridging data collection and statistical analyses delivers the supporting evidence necessary for a successful regulatory submission.

Solutions to Fit Your Needs

Depending on where you are in the planning and execution of your trial, our team can provide a tailored solution to meet the exact needs of your project. We are equipped to support large global organizations seeking specialized expertise to quickly augment their current team, as well as help niche developers in need of more immersive outsourced services from design through close-out.

Beaufort is ready to be your partner in providing strategic consulting, statistics, and statistical programming as a stand-alone service or bundled with comprehensive data management, clinical research, and regulatory consulting.

Statistical Consulting

  • Protocol review
  • Statistical methodology recommendations
  • Sample size estimation and power calculations
  • Participation in regulatory agency meetings

Statistics and Statistical Programming

  • Statistical Analysis Plan (SAP) development
  • Randomization development
  • Programming & validation of analysis datasets, tables, figures, and listings
  • Interim & final analysis planning & reporting
  • Preparation of interim analyses and reporting for submission to Data Monitoring Committees (DMC)
  • Clinical Study Report (CSR) preparation

Extensive Study Experience

Analytical Performance Studies

  • Precision/Reproducibility
  • Linearity/ Reportable Range
  • Specimen Stability
  • Reagent Stability
  • Analytical Sensitivity
  • Analytical Specificity (Interference)
  • Specimen Storage
  • Carry-Over/Cross-Contamination
  • Assay Cut-off

Comparison Studies

  • Method Comparison
  • Matrix Comparison
  • Companion Diagnostic Bridging Studies

Clinical Studies

  • Clinical Comparison / Performance Studies
  • Antimicrobial Susceptibility Test (AST) Systems

Clinical Cutoff Studies

Expected Value / Reference Range

Ready to get started? Contact us today.