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