SCDM EMEA 2026

Presenter: Rajesh Saha

As clinical trials grow more complex and automated, trust in data can no longer rely on expertise alone. Regulators and stakeholders expect clear evidence of data origin, transformations, and decision rationale—making trust something that must be designed, not assumed.

This session shows how a centralized Clinical Metadata Repository (MDR) enables transparency, traceability, and consistency across the data lifecycle. By capturing definitions, derivations, standards interpretations, and decisions in a governed, version-controlled system, MDRs make data meaning visible and defensible.

Attendees will learn how metadata-driven workflows reduce rework, support reuse, and enable reliable automation without losing explainability. The session also emphasizes the human role—stewardship, judgment, and accountability—in ensuring quality and clarity.

Ultimately, an MDR is not just a tool but a trust framework, combining technology, process, and human oversight to ensure confidence and inspection readiness in clinical data