Governance Powered CDISC Implementation: Driving Standards Reuse at Scale

About this session

Part of Session 7, Track A: Foundational Standards - SDTM (Chair: Alana St. Clair, CDISC).

Many organizations invest heavily in building a CDISC standards library with expectations of compliance, improved quality, and efficiency. While compliance and quality are often achieved, true efficiency remains elusive when standards function merely as static references rather than reusable, governed building blocks.
Alcon addressed this challenge by pairing strong governance with automation to drive high standards reuse across Pharma and Medical Devices. Automated comparison of study CRFs against the standards library and even against completed studies enables intuitive reuse recommendations, minimizes deviations, and reduces manual effort. Embedded quality checks within the standards library further accelerate SDTM and ADaM development and enhance cross-study consistency.
This presentation will describe how Alcon cultivated an enterprise-wide standards mindset and built a standards-powered ecosystem. Attendees will gain practical insights into how governance, automation, and actionable reporting can dramatically increase standards reuse, improve data quality, and unlock the full value of CDISC standards implementation.

Speaker

• MQ

  Minda Quiroz

  Alcon

  Speaker