Webinar
Rethinking eSource for eCOA, EDC, and Beyond: Moving from Data Origin to Convergence
Rather than debating where a data point originated, the real issue is how data needs to effectively converge to become defensible and submission-ready.
“eSource” has grown to be one of the more confusing terms in clinical research. Regulators have tried offering some clarity, such as defining eCOA data as source only upon its first point of permanent storage and not on the device it’s initially captured on. Yet this continues to be a point of confusion in the industry. Between direct data entry, EHR integrations, and expanding eCOA platforms, sponsors are left managing disparate repositories that claim to be “the source,” resulting in heavy downstream cost to timelines and negatively impacting data confidence.
Medidata and Fierce are convening a panel of subject matter experts, including a clinical site representative, a sponsor, and a regulatory expert, to reframe the question.
Using eCOA-to-EDC data flow as the clearest example, the panel will show what changes once eSource and secondary source data sit in one record.
Key Takeaways
- Clarify how “eSource” is actually defined across eCOA, EDC, and beyond and why that definition keeps blurring.
- Discuss various approaches and tradeoffs to reconciling data to reduce risk and improve trial timelines.
- Discover how the downstream value of a unified data foundation, from stronger risk-based monitoring to faster compliance and safety insights, can be achieved once all trial data converges in one place.