Biostatistical Consulting

We work with your team to identify key objectives from the regulatory, corporate, and scientific perspectives. We then incorporate the objectives into powerful study designs that prioritize key goals and de-risk the development program at strategic go/no-go decision points.

Our team can assist with:

• Study design and sample size calculations
• Development strategy
• Regulatory support, representation, and submissions
• Data monitoring committee (DMC) and scientific review committees
• Strategic product development plans
• Individual study protocol development including novel and complex trial designs, adaptive trial design, real-world evidence and/or other external controls, natural history studies, and patient registries
• Exploratory analyses for corporate or scientific support