Alira Health

PHUSE US Connect 2026

March 22–26, 2026 | Austin, TX, US

We are excited to attend and sponsor PHUSE US Connect 2026, an event that brings together the clinical data science community for a week of innovation, collaboration, and fresh perspectives.

During the event, Alira Health biometrics experts will lead a hands-on workshop, “The Role of Standards in a World of Agentic AI,” in collaboration with our partner Medidata.

Join our workshop and meet our team to learn how we help you reduce risk, streamline submissions, and approach regulatory review with confidence—by working as a true extension of your team.

About Our Hands-on Workshop “The Role of Standards in a World of Agentic AI”

Date: March 24 | 4:00 PM

Agentic AI is crashing the clinical research party – and it didn’t bother to read the CDISC standards first. As both regulators and industry start experimenting with AI agents that can think, reason and even code, we’re faced with a provocative question: if machines can interpret context, do they still need our tables? 

Our industry loves structure – SDTM, ADaM and Define-XML are practically comfort food. But large language models don’t think in columns and rows. So what happens when our AI ‘colleague’ skips straight from raw data to validated results without generating any of those beautiful interim datasets we’ve spent years perfecting (and years debugging)?

In this Hands-on Workshop, we’ll:

  • Play with agentic AI tools that automate clinical data transformations
  • Debate what happens to standards, traceability and sanity when our ‘junior programmer’ is an AI agent that never sleeps
  • Challenge our assumptions about what ‘standards’ mean in an AI-driven world.

Are we witnessing the evolution of clinical data workflows? Or their total disruption?
Come ready to code, question, and maybe commit a few heresies. By the end, you’ll have a clearer view of how AI could upend our current data standards – and whether that’s brilliant, terrifying, or a little bit of both.

Workshop Facilitator

Paula-Edwards headshot

Paula Edwards-Holmes
VP, Biometrics Outsourcing

Paula has been in the industry for over 30 years as a statistician, programmer, business portfolio manager and mentor in pharma, biotech and CRO companies. She has a strong track record in leading teams to deliver the statistical and programming aspects of clinical research projects from conception to completion whilst ensuring quality and regulatory compliance.

Meet Our Delegates

Laura Williams
Manager, Statistical Programming

Angelica Borgo
Business Developer, Biometrics General

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