Our Statistical Consulting Services begin by listening and understanding our clients’ product development goals. We deliver a decisive plan that will optimize cost containment, minimize redundancy, reduce project timelines, and achieve short and long-term goals. Our experts will advise you through the implementation process or will take an active role initiating change through our own functional teams. 

 

Our consulting services include

 

• Protocol/study design

• Sample size determination

• Randomization

• External, independent, unblinded statistician

• IDMC/DSMB support

• Regulatory Document review

• Data standards

• SOP writing

• Macro development

• Data Management

We can provide a total package—from beginning to end—from designing your trial to the final submission. This service would provide a one-stop solution for your statistical needs for your new drug development or novel discovery. Our total package includes, but is not limited to the following. 

• Clinical trial design

• Protocol development

• Power analysis/sample size calculation 

• CRF/Database Review

• Preparation of the Statistical Analysis Plan (SAP)

• Design and generation of Tables, Listings, and Figures 

• Interpretation and presentation of results

• Preparation of Clinical Study Report

• Preparation of datasets for regulatory submission

For companies without an internal biostatistics team, or with only a small internal team, Summit Biostats can work with you to develop a plan for how our biostatistics team can best support you.  For example:

• we can work with you as your biostatistical representative,

• we can support your internal biostatistics and programming team,

• we can oversee your biostatistics vendors as your representative.