| Versante provides expert statistical and analytical support that is second to none. We ensure appropriate statistical analysis and reporting that are consistent with the protocol and the statistical analysis plan. |
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| Statistical Analysis Services Include: |
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Consultation during protocol design |
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Develop Statistical Method’s Section for study protocols |
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Definition of endpoints |
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Conducting simulation studies to pick the best endpoints |
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Determination of appropriate statistical methodologies |
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Sample size and power analysis |
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Generation of randomization plans |
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Interim and final analysis of study data |
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Participation in Data Safety Monitoring Boards |
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Preparation for and representation of client case before regulatory authorities |
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| All plans are designed to comply with ICH guidelines and incorporate sponsor comments: |
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| Our biostatisticians keep current with the latest statistical techniques in the literature as well as those accepted by the FDA. Our senior biostatisticians have served as independent reviewers of major studies in many therapeutic areas. Our statistical programmers bring a wealth of knowledge of the latest programming techniques and features of the SAS system and other statistical software packages. We provide a library of standardized and tested templates, as well as great attention to details, to deliver high quality and dependable analyses. |
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