Agentic AI in Clinical Trials

August 14, 2025

Across the industry, many of us are rethinking data monitoring and wondering exactly how agentic and generative AI truly fit.

In this newsletter, we announce an upcoming class we’re hosting, give a quick look at how Ash, our Clinical Trial Agent™, gets you the answers you need without delay, and highlight a recent webinar we participated in.

— studyOS Team

How Agentic AI Can Help Clinical Data Science Professionals Implement ICH E6(R3)

You’re under pressure to modernize your approach to data review, monitoring, and quality. ICH E6(R3) is clear: responses must be risk-based, proportional, and documented. But translating that into everyday practice without just adding more work to already overburdened teams is anything but simple.

What if you could see how an agentic AI system is being designed, not as a dashboard or a tool, but as a digital colleague that helps your team deliver fit-for-purpose data across the full lifecycle?  

In early September, we’re launching a five-session working group with our Clinical Trial Agent™, built for the real-world work of:   

  1. Protocol as System: Structured logic as ingestion foundation

  2. Rethinking Review: Unified system for data cleaning + signal detection

  3. Designed for Validation: Explainable outputs. SQL you can inspect

  4. Governance + Scale: How intelligent systems become operational

This is a strategic cohort for leaders who want a direct hand in shaping how intelligent systems can integrate to augment CDM/CDS teams in data cleaning and monitoring, and what agentic systems must actually do to be useful:

  • What tasks should they take on?

  • What does meaningful AI augmentation look like in clinical data work?

  • How do we validate them and ensure they help rather than disrupt?

This cohort is about defining what these systems can do, should do, and how to make them a real part of your workflow, something your team actually uses, not works around.

🗓️ Starts mid-September | 5 sessions | Every other Thursday
📄 Shared output: Agentic AI as a Digital Colleague for Clinical Data Science

📩 For more details or to secure your spot, reach out to us at [email protected].

Get an immediate pulse check on your study

With Ash, our Clinical Trial Agent™, you can safely interrogate ePRO and audit trail data to get an immediate pulse check on what is happening in your study.

You can ask any question of your available ePRO data, as described in ICH E6(R3), so that gaps or unusual patterns are identified early rather than weeks later in a report. You can also understand the story behind your audit trails, seeing every change, who made it, when it was made, and why.

ICH E6(R3) makes it clear that audit trails are essential for reconstructing the sequence of events and verifying data integrity, so they can no longer be ignored.

Want to learn how you can take advantage of interrogating your data safely?

In case you missed it

At the end of July, our CEO, Ellis Hiroki Butterfield, joined TransCelerate and CDISC for the Digital Data Flow (DDF) Solution Showcase.

The panel explored how protocol digitalization can power more intelligent, connected clinical trial systems and how Ash, our Clinical Trial Agent, uses CDISC standards to streamline oversight.