Trial Design and Analysis
We have extensive expertise in the design, analysis, and interrogation of clinical trials, including pharmaceutical, biologics, and device registration trials. This knowledge comes from hands-on experience that encompasses a broad range of perspectives, including:
- Design and management of registration trials from within pharma
- Regulatory review of protocols and application data from within FDA
- Conduct of intervention trials and rigorous cost-effectiveness assessments as academic investigators and research methodologists

