How can real-world data support your regulatory submission?
- Accelerate clinical trial timelines
- Reduce recruitment burden
- Demonstrate drug performance in real-world populations
- Inform go/no go decisions
- Compare clinical trial results to real-world settings
How to define regulatory-grade data?
Provenance
- COTA oversees the entire process from abstraction of raw data to final delivery of curated RWD
- Traceability of all our data: where it originates, the transformations applied, and QA checks along the way
- Allowance of full auditability by regulators and other stakeholders
Relevance
The right cohorts after applying inclusion/exclusion criteria at the right volumes
Representativeness across real-world and clinical trial populations
Coverage across geographies of interest
Fidelity
- Faithful representation of the original clinical data documented in EHR
- Technology-enabled human abstraction leveraged to understand and capture clinical nuances
- Accuracy of capture ensured through documented, multi-step QA/QC process
How to generate regulatory-grade data?
Our data has been used to support FDA and EMA submissions, explain care patterns, understand patient outcomes, and much more.
See how we are collaborating with the FDA using RWD
