Biostatistics

Services include, but are not limited to, the following:

  • Clinical Studies
    • Support for Phase I-IV, Feasibility+Pivatol, and Observational Clinical Studies
    • Study Design and Sample Size/Power Estimation
    • Protocol Development
    • Statistical Analysis Plans (SAP)
    • Tables, Figures, and Listings (TFL) Shell Development
    • Statistical Analyses and Programming
    • Clinical Study Report Writing/Reviewing
      • Clinical Study Statistical Memos Summarizing Results
      • QC efforts verifying accuracy of results
  • Regulatory Support
    • Submission Support
      • NDA /MAA/BLA
        • SAPs for Integrated Summaries
        • Statistical Analyses for Integrated Summaries
        • Writing/Reviewing of Statistical Sections of Integrated Summaries
        • Reviewing of Clinical Summary and Clinical Overview
        • Reviewing other sections as necessary
        • QC efforts verifying accuracy of results of applicable CTD sections
      • PMA
        • Writing/Reviewing Overview Section
        • Writing/Reviewing Clinical Data and Information Section
        • Writing/Reviewing Summary of Safety and Effectiveness Section
        • Reviewing Directions for Use Section
        • Reviewing other sections as necessary
          • QC efforts verifying accuracy of results of applicable PMA sections
      • 510(k)
        • Writing/Reviewing Performance Testing – Clinical Section
        • Reviewing Substantial Equivalence Discussion Section
        • Reviewing Proposed Labeling Section
        • Reviewing other sections as necessary
          • QC efforts verifying accuracy of results of applicable 510(k) sections
      • Regulatory Response
        • Face to Face meetings
        • Teleconferences
        • Written Communications
        • Phase IV/Post-Approval Study planning
      • Advisory Committee Support
        • Strategy/Planning of Key Messages
        • Developing Q&A materials
        • Conduct Adhoc Analyses
  • Additional Supporting Activities
    • Manuscript/conference presentations support
    • Preparation for and participating in FDA audits of Clinical Data
    • Statistical input for product life cycle program planning