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Consulting

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

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Outsourcing

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

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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.