New Framework Proposes Risk-Based Governance for AI in Clinical Development

COLUMBIA, Md., April 20, 2026 — Advarra, the market leader in IRB oversight and a leading provider of connected, intelligence-powered research technology, today announced the release of a new framework proposing a risk-based approach to governing artificial intelligence (AI) across the clinical development lifecycle. The framework introduces a practical model that provides organizations with a structured way to scale governance as AI systems become more autonomous and influential in trial design, operations, and evidence generation.

The framework is the first deliverable from the Council for Responsible Use of AI in Clinical Trials, a cross-industry body convened by Advarra and announced in June 2025. Founding members of the Council include executives from Sanofi, Recursion, and Velocity Clinical Research, bringing together senior leaders across biopharma R&D, AI-native drug discovery, and site-level trial operations to develop practical, consensus-driven guidance for responsible AI adoption in clinical research.

“AI is now embedded across nearly every stage of clinical development, from protocol design to data monitoring and reporting,” said Laura Russell, senior vice president of product, AI, and innovation at Advarra and chair of the Council. “As more advanced model-based and computational approaches begin to inform clinical evidence and trial design decisions, governance must evolve just as quickly to ensure innovation remains responsible and patient-centered.”

The newly released framework evaluates AI applications across two dimensions: level of autonomy—how independently a system initiates or executes actions—and degree of patient impact, reflecting how directly AI outputs influence participant safety, trial access, monitoring strategies, and the validity and interpretation of clinical evidence. This risk-based approach moves away from uniform, tool-agnostic controls in favor of oversight that reflects how AI is deployed within clinical and operational workflows.

“There is tremendous interest in applying AI in clinical trials, but many solutions still overlook the practical realities of how trials operate day to day,” said Raghu Punnamraju, chief technology officer of Velocity Clinical Research. “The real opportunity lies in focusing on tools that reduce operational friction, support better decisions, and make the work of investigators and study teams more manageable.”

Spanning all clinical development, the framework supports consistent governance across a wide range of AI use cases, from routine decision support to more autonomous applications that influence core clinical workflows with embedded intelligence.

“As AI tools become more integrated into clinical research workflows, the field needs shared approaches to regulatory oversight, compliance, transparency, and scientific validity,” added Jonathan Helfgott, former U.S. Food and Drug Administration official and Johns Hopkins University faculty member. “Efforts like this help advance the conversation around how to responsibly evaluate and govern AI in clinical research.”

The full report, including the framework and supporting analysis, is available on Advarra’s website.

Members of the Council and Advarra AI leaders will also be on-site at this year’s SCOPE X conference in Boston, May 18-19, 2026, to connect in person on this and other AI initiatives.

Media Contact

Michelle Valentine
michelle.valentine@advarra.com / mediarelations@advarra.com

About Advarra 

Advarra provides the platform, insights, and expertise that make clinical trials more efficient and connected. As the leading independent IRB, we bring more than 40 years of trusted oversight to the industry, setting the standard for ethical reviews while building the largest collection of digitized protocols and operational data. This combined intelligence guides the protocol’s entire journey—from design through review, activation, and conduct—fueling a smarter, more adaptive research ecosystem. 

Backed by decades of partnership with research sites, Advarra delivers the core systems and services that 50,000 investigators and their study teams depend on for optimal trial operations. Integrated with our solutions for study design, startup, and conduct, these capabilities create a collaborative technology platform trusted by sponsors and CROs globally. 

By designing AI-powered workflows that streamline operations, reduce administrative burden, and promote transparency for all study stakeholders, we’re reimagining what’s possible in clinical research. Learn more at www.advarra.com.