Advarra Establishes AI Council in Partnership with Life Sciences Leaders to Drive Collaboration and Advance Innovation in Clinical Trials

Sanofi, Recursion, and Velocity Clinical Research Executives Join Council as Founding Members to Guide Responsible AI Use in Clinical Research and Drive Tangible Improvements in Study Design and Operational Outcomes

WELLSELY, Mass., June 18, 2025 /PRNewswire/ -- Advarra, the market leader in regulatory review and clinical research technology, today announced the launch of the Council for Responsible Use of AI in Clinical Trials. The Council, which includes leaders from across the life sciences industry, will focus on setting standards, strengthening model governance, and defining measurable outcomes to advance the use of AI throughout the clinical trial lifecycle.

This collaborative initiative builds on Advarra's unique vantage point into study dynamics and the operational challenges faced by research sites, sponsors, and CROs, and draws upon the Company's trusted position in the clinical trial ecosystem. Leveraging this position to facilitate cross-industry dialogue and knowledge-sharing, Advarra is establishing the Council with leaders from Sanofi, Recursion, and Velocity Clinical Research who will serve as founding members. Together, they bring deep expertise in AI and machine learning, research and development, regulatory science, data strategy, and clinical operations.

"AI is shaping the future of clinical research, but its impact will only be as powerful as our ability to use it responsibly, collaboratively, and transparently," said Gadi Saarony, CEO of Advarra. "With the launch of the Council for Responsible Use of AI in Clinical Trials and the addition of significant AI and data science expertise to our team, we're doubling down on our commitment to driving meaningful, standards-based innovation—ensuring AI doesn't just move faster, but moves in the right direction for trial participants, sites, sponsors, and the broader research community."

Echoing this vision, Laura Russell, senior vice president, head of data and AI product development added: "The FDA's recent draft guidance has energized the life sciences community by recognizing AI's transformative potential, but it also highlights a pressing need for clarity—especially when it comes to real-world implementation, regulatory expectations, and how we ensure AI delivers measurable value. Advarra will not only address these challenges but also set a bold vision for the future—guiding the responsible use of AI to unlock new possibilities in clinical research and ultimately improve patient outcomes."

The Council will prioritize defining and accelerating responsible AI applications in clinical trials, addressing pressing operational needs, data security, and system interoperability.

To support these priorities, the Council will pursue several key goals, including:

• Developing a shared vision for AI's role in transforming clinical trials
• Establishing standards, guardrails, and shared frameworks for the safe, effective, and ethically sound use of AI
• Defining KPIs and metrics to evaluate both short-term efficiencies and the long-term impact of AI across clinical development timelines

"As AI becomes increasingly embedded in clinical development, it's essential that we come together as an industry to align on real-world best practices—not just theoretical frameworks," said Michel Rider, global head of digital R&D at Sanofi. "The Council for Responsible Use of AI in Clinical Trials brings together stakeholders from across the clinical research ecosystem, creating a unique opportunity to shape practical, scalable approaches to AI governance and implementation."

Sid Jain, senior vice president, clinical development & data science at Recursion, said, "This Council is one of the few forums specifically focused on how AI can be responsibly applied within the operational realities of clinical trials. There's growing momentum around applying AI to real-world and operational data—including protocol amendments and enrollment dynamics—to improve speed, precision, and decision-making. We are excited to work alongside others who are committed to turning that promise into measurable impact that helps bring effective treatments to patients sooner."

The Council for Responsible Use of AI in Clinical Trials will publish its findings and recommendations in white papers, peer-reviewed publications, and conference presentations. It will also lead public webinars and host cross-industry roundtables to promote transparency, knowledge-sharing, and collaboration. The Council will engage with standards bodies, regulatory authorities, and industry organizations to invite feedback, ensuring its work is forward-thinking and applicable across the research ecosystem.

To learn more about the Council for Responsible Use of AI in Clinical Trials or to request information about participation, visit https://www.advarra.com/council-for-responsible-use-of-ai-in-clinical-trials/.

About Advarra
Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Advarra is number one in research review services, a leader in site and sponsor technology, and is trusted by the top 50 global biopharma sponsors, top 20 CROs, and 50,000 site investigators worldwide. Advarra solutions enable collaboration, transparency, and speed to optimize trial operations, ensure patient safety and engagement, and reimagine clinical research while improving compliance. For more information, visit advarra.com.

SOURCE Advarra