Innovative approaches to stay ahead of regulatory change
Regulatory authorities are increasingly seeing the value of real-world evidence (RWE) to evaluate product’s safety and effectiveness. This changing environment offers opportunities to enhance evidence generation.
Our global, scientific, and operational experts are developing innovative methods for real-world evidence generation, including innovative study design and execution that combines secondary and primary data directly from patients and physicians. Applications include
- Expanded Access Programs (EAPs)
- Phase IIIB/IV studies
- Label Expansion studies
We help you meet regulatory needs through our extensive scientific experience in using RWE to accelerate approvals and label expansions in the US and EU. We are actively involved in developing new paradigms for regulatory approval including MIT NEWDIGs, National Evaluation System for Medical Technology, as well as ENCePP, EUnetHTA, IMI, and others.
Expand your study options with IQVIA’s rich breadth and depth of global and local data assets.Stay on top of growing regulatory demands.
By: Marni Hall