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.