Services > Biostatistical Services

We conduct Phase I through Phase III multi-institutional trials

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 trials.

Among the services we offer are:

• Design of clinical trials, including selection of most appropriate endpoints and sample size and power calculations
• Development of Statistical Analysis Plans (SAPs)
• Development and generation of interim analyses
• Participation on Data Safety Monitoring Committees (DSMC)
• Generation of DSMC reports and providing Independent Statistician in support of DSMC Meetings
• Review of electronic case report forms for compliance to Clinical Data Acquisition Standards Harmonization (CDASH) standards
• Developing and maintaining web-based reports on protocol status, survival endpoints, response and toxicities
• Analyzing clinical and correlative data for peer-reviewed manuscripts, scientific abstract submissions and presentations
• Preparing materials for and participating in FDA meetings

Our biostatisticians provide other cancer-related services including:

• Analysis of high-dimensional data such as gene expression and single nucleotide polymorphism (SNP) data to identify reproducible genetic markers
• Statistical support to cancer staging projects
• Cutting edge methodological research on novel clinical trial designs.