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Dawn Wydner

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Articles

07.03.26 -- Optimize Your Trial Data Journey

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By Dawn Wydner, Amanda MacGregor
| Clinical Leader Verified
Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials Learn from ex-FDA and ELIQUENT consultant Dawn Wydner, Ph.D.., how treating data integrity as an end-to-end clinical information flow issue, rather than a database-only concern, is essential to managing AI-related risk.
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Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials

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By Dawn Wydner
| Clinical Leader Verified
By Dawn Wydner, Ph.D., senior vice president, regulatory compliance, ELIQUENT Life Sciences In clinical research, data integrity is not just about whether a data point is accurate in the database. It depends on the integrity of information flow across the full trial life cycle: how data is captured at the site, transferred into sponsor systems, reviewed by CROs, transformed for analysis, included in essential records, and ultimately used to support safety, efficacy, and regulatory decisions.
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