The Real World Data Program is designed to increase Health Authority confidence in Real World Data (RWD) / Real World Evidence (RWE) for regulatory decision-making.
- Tools To Consider When Engaging Health Authorities: Gaining internal sponsor cross-functional buy-in and alignment during study design on required inputs and decisions that need to be made in order to include RWD/E in regulatory decision-making.
- Considerations For Data Relevance and Reliability: Targeting data relevance and reliability to aid quality management oversight of RWD, including inspection readiness, in a manner suitable for regulatory decision-making.
Considerations For Data Relevance and Reliability
The RWD Audit Readiness solution will be released in late 2022 / early 2023.