Study Design

To meet our clients’ needs, BSSI provides statistical consulting on some of the more complex aspects of study design for both clinical and non-clinical studies:

  • Study design development and/or evaluation of various designs (e.g. multi-reader, multi-case, device approvals, pivotal animal studies)
  • Methodologies for randomization, stratification, and blinding
  • Calculation of sample sizes necessary to meet both power requirements and study budget
  • Advanced statistical methodology needed to evaluate the research question (e.g. drug/biologic or device efficacy, assay validation, predictive biomarkers)
  • Statistical analysis plan (SAP) and protocol development/review

In addition, our personnel have extensive experience with the advanced statistical methodologies required for adaptive study designs (now commonly utilized in the oncology space and in rare diseases).