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Using RWD and RWE to Support an Ultra-Rare Orphan Program

Clinical trials for ultra-rare diseases can be particularly challenging to mount. Typically, the patient population is small and geographically diverse. The FDA may allow the use of credible real-world data (RWD) and real-word evidence (RWE) in lieu of data collected in a Phase 3 trial

Multidisciplinary Team Advances Immuno-Oncology Development

Date: July 24, 2020 Author: Ruth Stevens, PhD, MBA Project Lead: Stacey Ayres, PhD In this in-depth case study for an immuno-oncology program, discover how Premier Consulting's multidisciplinary development strategy assessment reduced a sponsor's risk, controlled expenses, and optimized speed to market. Download the Case