QUINTESSENTIAL’s biostatisticians have extensive knowledge of statistical methodology for drug and device development, various study designs, and regulatory requirements. They are experienced in a broad range of therapeutic areas and add value to your projects. Clients appreciate the reliability and the proactivity of the team.
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Planning and Analysis of Phase I – IV Studies and Observational Study
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Study Design
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Proof of concept or dose-finding
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Superiority/Non-inferiority/Bioequivalence
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Flexible designs
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Statistical input into Study Protocol/Observational Plan
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Sample Size Estimation
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Randomization
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Statistical Analysis Plan, Table Plan, Table Shells and Analysis Dataset Specifications
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Statistical Data Review
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IDMC Support or IDMC Statistician
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Analysis
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Interim and final analysis for clinical studies