Real World Data Solutions

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.

Multiple stakeholder groups can benefit from greater use of RWD,​ but several challenges limit uptake. Our tools provide sponsors with RWD specific:

  • 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.