We can support sponsors for the following strategies around real world data (RWD) and RWE:
- Design of post-marketing or safety surveilence 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 (Bayesian) study designs for rare diseases and for areas with high unmet needs into interim and final analyses.