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The Tii statistics group is involved throughout the life of a project—including study design, development of study materials, data summary reporting, statistical analysis, and publication—to ensure that each project is grounded in sound statistical methods. Our approach to statistical support is to work closely with the client, identifying specific analysis needs. Whether the needs involve statistical programming, interim analyses, data summaries, final analyses, or statistical writing, we are committed to working with you to provide a quality product.

We provide the following biostatistical services in support of your clinical trials on a routine basis:

Study design Sample size calculations Protocol review and consulting CRF review Randomization SAS® programming (PC SASR v9.1) Audited tables, figures and listings Interim and final analyses

Statistical reporting Clinical study report review Common technical document support Data Monitoring Committee (DMC) support Regulatory agency support and interaction including FDA EMAA and other regulatory agencies Annual safety updates Consulting and training Database integration for integrated summaries (CTD, NDA)

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