How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations.

Cary discusses why data governance has become urgent across three fronts — structured submissions, cross-functional interoperability, and AI reliability — and walks through the foundational steps companies should take, the organizational challenges they'll hit, and what measurable results look like when governance is done right.

A few of Cary's key takeaways:

Regulatory submissions are no longer just documents — they're structured data that demands consistent master data, controlled vocabularies, and traceable lineage
Start with scope and pain points, not a boil-the-ocean exercise — pilot governance in one or two high-value use cases, then scale
Data ownership belongs in the business, not IT — IT facilitates, but stewards and business owners should be accountable for their data
Tools support governance but don't replace it — get the people and process foundation right before selecting platforms
AI reliability depends on governed data — without standardized inputs and clear provenance, models produce unreliable or unexplainable outputs
Tie governance to business outcomes people are already measured on — submission cycle time, audit readiness, right-first-time metrics — or compliance won't stick

About Cary SmithsonCary Smithson is Managing Partner and Owner of LeapAhead Solutions, Inc., where she leads a consulting practice focused on IT strategy, data governance, and business process consulting for life sciences. She leads the DIA RIM Working Group and the DIA RIM Intelligent Automation Team and co-authored the DIA RIM eBook. With experience spanning large consulting firms (Grant Thornton, PharmaLex), enterprise technology organizations (OpenText), and her own practice, Cary has served clients including Regeneron, Bristol-Myers Squibb, Johnson & Johnson, Daiichi Sankyo, Bayer, and BeiGene. She is a recognized thought leader who regularly presents at industry conferences on regulatory information management, intelligent automation, and AI adoption in life sciences.

About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson

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