Statistics for Screening & Confirmatory Cut-Points

B2S provides statistical services for estimation of screening and confirmatory cut-points. Contact us today to request information regarding these services.

Services and deliverables considered within scope for the determination of screening and confirmatory (inhibition) cut-points include:

  • Upfront collaboration on study design and data reporting formats
  • A critical review of the validation study design
  • Collaboration with the sponsor to determine the desired format for submission of study data to B2S Consulting
  • Collaboration with the sponsor to resolve any data quality issues that may arise
  • Specification of statistical methods to assess fixed and random sources of variation and distributional assumptions, and specification of algorithms to calculate cut-point values
  • Completion of all specified statistical analyses using validated software. Statistical methods and algorithms used in the data analysis are consistent with procedures recommended by Shankar G, et al (2008), Journal of Pharmaceutical and Biomedical Analysis 48, 1267-1281.
  • Completion of an independent verification of critical analysis steps using different statistical software
  • Completion of a written statistical report that summarizes the data, statistical methods, and analysis results associated with the determination of cut-point values
  • Submission of a draft statistical report to the sponsor for review
  • Incorporation of emendations from sponsor to create a final statistical report
  • Submission of the final statistical report to sponsor for signature of approval
  • Addition of B2S Consulting signature to the final statistical report
B2S Life Sciences