Supplementing or replacing clinical trial data with Real World Data (RWD) to inform regulatory decisions is a transformative, ambitious goal that has the potential to substantially contribute to the totality of evidence regarding the benefits and risks of drug products. Leveraging RWD can benefit patients, researchers, and regulators, among others.
- Enhanced evidence generation through RWD potentially leading to improved patient outcomes
- Enhanced credibility and increased awareness of appropriate use of RWD
- Increased confidence in acceptance of RWD for regulatory decision making
For more information and to explore our solutions, visit our Initiative Solutions page.