Biostatistics

We provide the following services under Biostatistics:

Study Design:

  • Advice on Matters of Study Layout
  • Evaluation of the Optimality of Selected Efficacy Parameters in Terms of Statistical Properties
  • Sample Size Determination
  • Statistical Analysis Plan Composition

Data Analysis:

  • Blinded Data Review
  • Interim Analyses
  • Review of Third-Party Data Analyses
  • Data Analysis for Studies Spanning Drug Discovery – Phase IV
  • Submission-related Statistical Support

General Statistical Consulting:

  • Assistance with the Composition of Statistical Results Summaries for Clinical Study Reports
  • Assistance with the Creation of Manuscripts, Posters & Oral Presentations for Internal/External Presentations
  • Advice on Data Visualization (Statistical Graphics)
  • Review of Statistical Matters Pertaining to Compound Acquisition, New Methods Development, Technology Acquisition or External Published Claims

Other Services:

  • Creation of Custom-Designed Courses for Teaching Statistics to Non-Statisticians
  • Instruction in Basic Statistical Methods for Non-Statisticians
  • Assistance with the Creation of SAS® Tools (Macros) for Statistical Analyses Not Currently Available in the STAT Product

Regulatory Submission Support Based on Strong Science and Strength of Process. The difference is in the data!

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