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
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Protocol/study design
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Sample size determination
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Randomization
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External, independent, unblinded statistician
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IDMC/DSMB support
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Regulatory Document review
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Data standards
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SOP writing
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Macro development
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Data Management
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.
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Clinical trial design
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Protocol development
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Power analysis/sample size calculation
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CRF/Database Review
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Preparation of the Statistical Analysis Plan (SAP)
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Design and generation of Tables, Listings, and Figures
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Interpretation and presentation of results
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Preparation of Clinical Study Report
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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:
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we can work with you as your biostatistical representative,
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we can support your internal biostatistics and programming team,
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we can oversee your biostatistics vendors as your representative.