Biostatistics

BSSI has been providing statistical consulting services since 2001. We assist with all aspects of design, analysis and interpretation of experimental and clinical research studies.

  • Support for the development of drugs, biologics, and medical devices;
  • Strategic planning, study design, power and sample size, clinical protocols, Statistical Analysis Plans (SAP);
  • Development of Clinical Data Interchange Standards Consortium (CDISC) compliant data sets for regulatory submissions
  • Tables, figures and listings (TFL), Statistical Analysis Reports (SAR), Clinical Study Reports (CSR), and manuscript support;
  • Assay analytics including assay qualification and validation (e.g. diagnostic assays, anti-drug antibody assays);
  • Extensive experience in the design, analyses and interpretation of biomarker studies, including early phase biomarker discovery;
  • Regulatory strategy and support.