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Date: Thursday, March 26, 2026

Time: APAC 10:00-10:45am IST, EMEA 9:00-9:45am GMT, Americas 2:00-2:45pm ET

Summary

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.

Register now


Who should attend:

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

Speaker:

Rajesh Saha

Pinnacle 21 Subject Matter Expert and Senior CDISC Consultant

Rajesh Saha is a Pinnacle 21 Subject Matter Expert and Senior CDISC Consultant at Certara with 15+ years of experience in clinical data standards and regulatory submissions. He specializes in SDTM, CDASH, Define.xml, and metadata-driven implementations, enabling efficient, compliant, submission-ready data. Rajesh is also an authorized CDISC instructor with deep expertise in standards-based data quality and validation.

Register now