Laura Russell, SVP, Head of Data & AI Product Development at Advarra, introduces the Council and its commitment to bringing together stakeholders from across the life sciences industry to develop standards and shared frameworks for the use of AI in clinical research.
Paving Pathways for AI in Clinical Research
The clinical research industry is eager for guidance and tangible solutions when considering how and where to leverage AI. The Council’s ultimate goal is to collectively define responsible AI use in clinical research and align on practical, impactful AI use cases that will drive meaningful improvements and operational efficiencies. Members will focus on standards, strengthening model governance, and defining measurable outcomes to ensure AI delivers value to patients and other clinical research stakeholders.
Council Key Priorities
In addition to developing standards and frameworks, 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. The Council will also lead public webinars and host cross-industry roundtables to promote transparency, knowledge-sharing, and collaboration.
Founding Organizations
“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. The Council for Ethical 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.”
“This Council is one of the few forums focused specifically on how AI can be responsibly applied within the operational realities of clinical trials. While progress has been made, there’s a major opportunity to apply AI to real study data—such as enrollment trends and protocol amendments—to truly optimize trial operations. We’re excited to collaborate on turning that potential into measurable impact.”
“At Velocity, we’re dedicated to harnessing the power of AI to transform clinical trials, enhancing efficiency, supporting site staff, and improving the patient experience. Our commitment to developing proprietary agentic AI solutions, grounded in the safe and ethical use of AI, supports our mission and positions us to contribute meaningfully as a founding member of Advarra’s AI Council. We look forward to working with industry peers to shape best practices that are scalable and practical, ensuring AI benefits everyone in the research ecosystem, especially the patients we serve.”
“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. Together, we 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.”
“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. 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.”
NEWS
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
FAQs about the Council for Responsible Use of AI in Clinical Trials
What is the Council for Responsible Use of AI in Clinical Trials?
The Council for Responsible Use of AI in Clinical Trials is an industry-wide initiative established by Advarra that is bringing together stakeholders from across the industry, including sponsors, research sites, and technology partners to define standards, guardrails, and shared frameworks needed for safe, effective, and ethically sound use of AI across the clinical research lifecycle.
AI adoption in clinical trials is accelerating rapidly, with tools already being used for trial design and feasibility, patient recruitment and enrollment, data monitoring, and more. Much of the conversation to date, however, has centered on speed and efficiency. There is a need to address considerations regarding ethics, transparency, and oversight.
This is a collaborative, non-commercial effort grounded in a shared commitment to improving research quality and leveraging advances in AI to power clinical research.
Who are the Council members?
The Council’s members represent a cross-section of the clinical trial ecosystem, including sponsors and research sites. Members were selected for their expertise and commitment to scientific rigor and ethical research. Executives from organizations, including Sanofi, Recursion, and Velocity Clinical Research, are the founding members of the Council.
Advarra is serving as the convener and facilitator of the Council, as well as a member, providing the infrastructure, managing its operations, and participating in workstreams as applicable.
What work will the Council prioritize?
The Council will address the frameworks needed to guide AI adoption responsibly across all phases of clinical research. Key priorities include addressing standards, interpreting regulatory guidance, defining KPIs to measure the value and impact of AI solutions, embedding bias mitigation strategies and privacy protections in models, and advancing collaboration across industry stakeholders. Through this work, the Council aims to create practical, ethical, and forward-looking resources that support the integration of AI in clinical trials.
Will the Council’s findings and frameworks be shared publicly?
Absolutely. Transparency is a core principle of the Council’s work. The Council’s final findings, frameworks, and recommendations will be made publicly available to support trust, accountability, and consistent, ethical AI adoption across the research ecosystem. To ensure broad access, the Council’s materials, updates, and insights can be easily accessed by the entire community via the Advarra.com website.
The Council’s strategy is to develop clear, actionable guidance—and then invite broad feedback from across the research ecosystem, including sponsors, sites, regulators, and technology partners. We recognize that adoption takes time, so our approach is iterative: we’ll refine the recommendations based on real-world use, evolving standards, and stakeholder input.
The Council plans to publish working group outputs beginning in late 2025. Initial frameworks and guidance are expected to be released in early 2026.