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日期: 2026 年 3 月 26 日, 星期四

时间: APAC 11:00-11:45am IST, EMEA 9:00-9:45am GMT, Americas 2:00-2:45pm ET

概述

Trust in clinical data is no longer a quality aspiration, it is a regulatory expectation and a risk management imperative.

Health authorities are increasingly scrutinizing not just the data itself, but how it was created: its provenance, transformation logic, deviations from standards, and decision history. At the same time, organizations are reusing data across submissions, regions, automation pipelines, and AI-driven processes, raising the stakes for consistency and explainability.

So how do we engineer trust into clinical data?

In this webinar, Rajesh Saha explores how Clinical Metadata Repositories (MDRs) provide the foundation for transparency, traceability, and defensible decision-making across the study lifecycle. Through practical use cases, including standards deviations, EPOCH derivation inconsistencies, automation failures, and regulatory inquiries, you’ll see how governed metadata transforms reactive investigations into proactive assurance.

We’ll discuss:

  • Why trust in data is now a regulatory and business risk issue
  • How data loses trust – and how to prevent it
  • The role of metadata in enabling version control, audit trails, and lineage
  • How MDRs support explainable automation and AI
  • The shift from “data owners” to enterprise metadata stewards
  • How to balance automation with human judgment and accountability

You’ll leave with practical steps to embed transparency and traceability into your organization, and a clear understanding of why trust is the currency of scientific credibility.

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Who should attend:

Clinical data leaders, standards managers, biostatisticians, regulatory professionals, data governance teams, and anyone responsible for submission-ready data.

主讲人:

Julie Ann Hood

Principal Consultant

Julie Ann Hood is a Principal Consultant at Pinnacle 21. She received her Master’s Degree in Psychology from the University at Buffalo where she completed the Behavioral Neuroscience program and embarked on her drug development journey in pre-clinical research at the Research Institute on Addictions. After transitioning into clinical research as a Data Manager and being introduced to CDISC, she gained over 10 years of experience consulting on submission readiness and clinical data standards development.

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