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
Sample size determination
External, independent, unblinded statistician
Regulatory Document review
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
Power analysis/sample size calculation
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
Insourcing (Functional Service Provider Solution)
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.