Services

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We provide strategic and technical leadership across multiple phases of product development including but not limited to clinical development planning, regulatory interactions, study design/conduct/analysis, study result interpretations, and publications. 

 We provide strategic oversight with CROs in regard to data management and statistical activities, including identifying suitable partners, defining CRO responsibilities, and maintaining interactive management.  

 We provide support through an independent statistician or a DSMC member statistician. 

Step in as a project/study statistician to work with the cross-functional team to design and operationalize clinical trials and be accountable/responsible for statistical deliverables such as:

• Inputs to study schema and other study documents (e.g., DSMC charters)
• Sample size and power calculation
• Randomization schema
• eCRF review
• Statistical analysis plan, table shells, and analysis outputs (e.g., TLFs)
• Ad hoc and post hoc analyses
• Presentation materials at scientific and investor conferences