Biostatistical Services

The design and analysis of a wide variety of oncology clinical trials constitutes the majority of our work. Trials range from Phase I single or multi-institution industry sponsored to Phase III multi-institutional cooperative group trials. Some clients request only a subset of our clinical trial statistical services.

Among these are:

  • Design of clinical trials, including selection of most appropriate endpoints, and sample size and power calculations
  • Development of Statistical Analysis Plans (SAPs)
  • Perform interim analyses
  • Write Data and Safety Monitoring Committee (DSMC) reports and participate on DSMCs
  • Serve as Independent Statisticians to support DSMC
  • Develop and maintain web-based reports on protocol status, survival endpoints, response and toxicities
  • Analyze clinical and correlative data for peer-reviewed manuscripts, scientific abstract submissions and presentations
  • Prepare materials for and participate in FDA meetings

Our biostatisticians provide other cancer related services, including:

  • Analysis of high-dimensional data such as gene expression and SNP data to identify reproducible genetic markers
  • Cancer staging projects
  • Collections and analysis of data on cancer outcomes

Finally, CRAB statisticians are involved with cutting-edge methodological research on novel clinical trial designs.

CRAB is a member of the Clinical Data Interchange Standards Consortium (CDISC), an international, non-profit organization that develops and supports global data standards for medical research. We support and implement CDISC standards as appropriate in the conduct of research.