Real World Data

The Real World Data (RWD) Initiative aims to collaborate with global regulatory agencies and other stakeholders to develop a framework for RWD that provides tools, methodologies, case studies, and appropriate levels of evidence to support regulatory decision-making.

Rationale

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.

Benefits

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

Available Solutions

Initiative Solutions

For more information and to explore our solutions, visit our Initiative Solutions page.

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