We can support sponsors for the following strategies around real world data (RWD) and RWE:

• Design of post-marketing or safety surveillance trials.
• Curation, validation and analysis of RWD from identified sources (EHR, Insurance claims data, etc.) tailored to the study objectives.
• Linking of RWD to RCT data.
• Mining of RWD, for example for identifying sub-populations of special interest and for estimating effects that would inform design of future studies.
• Incorporating RWE into interim and final analyses of (Bayesian) study designs for rare diseases and for areas with high unmet needs.
• Implementing causal inference based on methods such as propensity score, inverse probability of treatment weighting, machine learning-based methods such as causal random forests etc.