Biometrics

Partner for Biometrics: Instat

Statistical Analysis

 

Statistical Programming

Statistical Aspects of Study Design

  • Protocol Development/Experimental Design Consulting
  • Sample Size/Power Calculations
  • CRF Review
  • Randomization

Statistical Analysis Planning

  • Analysis planning meetings
  • Methodology development and evaluation
  • Production of analysis plan/interim analysis plan
  • Production of mock tables, listings, and graphs

Data Analyses

  • Specification and programming analysis derived datasets
  • Analysis dry-run
  • Formal interim and final analyses
  • Post-hoc and exploratory analyses
  • Blind review of protocol violations
  • ISS/ISE analysis

Reporting

  • Stand Alone Statistical Reports
  • Integrated Clinical Study Reports
  • Tables, listings, graphs, and statistical appendix
  • Sponsor, FDA, and conference presentations

Statistical Consulting

  • Consulting on Statistically Related Regulatory Issues
  • Abstract and publication analysis and writing
  • Data Analyses and Support for Clinical Publications
  • Service on Data Monitoring Committees and Data Safety Monitoring Boards
  • Interface with regulatory authorities

Quality Control Services

  • QC and critical review of client analysis and reports
  • Independent validation of statistical programming (reprogramming and review)

 
  • Statistical programming for listings, tables and figures
  • Integration of safety or efficacy databases
  • SAS Macro development for statistical methods or report generation
  • SAS interface to Oracle Clinical
  • On-site or off-site programming resources by study or for every study
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