| Versante has the expertise to create optimal study designs and develop protocols for research programs that extend from small dose-finding safety studies to large pivotal trials. |
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| Our personnel have the experience and the knowledge in all phases of clinical research and offer leadership and expertise in the following areas |
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Biostatistics |
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SAS Programming |
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Regulatory compliance |
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Data Operations |
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Analyses |
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| The following is a summary of protocol development services |
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Study design |
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Evaluation of key endpoints |
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Statistical methodology |
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Case report form design and completion guidelines |
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Literature review and meta-analysis |
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Client representation at regulatory meetings (INDs, NDAs) |
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