EMA real-world evidence research requests could not proceed beyond feasibility, largely because available data were not fit for purpose.
EMA, cited in Clinical Pharmacology & Therapeutics, 2024
of respondents from regulators, HTA bodies and industry already using real-world data reported data quality as an obstacle.
Depner et al. 2025. Key Stakeholders' Knowledge, Opinions, and Interests on Real-World Evidence in the Regulatory Process, Clinical and Translational Science
Operational foundations work best when they are in place before evidence generation begins.
In practice, many organisations come to this later, with procedures, vendor arrangements and data governance that have grown up study by study.
We can support the development of new documentation, review what you have, or check existing processes against current requirements.
The work covers how vendors are assessed, selected, managed and monitored; the processes that govern real-world evidence activities from study initiation through to reporting; and data governance, including fitness for purpose of data sources, quality across studies and traceability.
Take Real-World Research Further
If you would like to discuss a programme, please get in touch.