AGENDA 2026

Registration & Coffee

Redefining Monitoring: The Future of Clinical Monitoring in an AI-Enabled World

This opening keynote will set the stage for the conference by examining how emerging technologies are changing the way CRAs monitor trials, and what this means for oversight, accountability, and the evolving role of the CRA.

What sponsors want from CRAs: expectations, green flags, and what makes a monitor truly stand out

Sponsors invest heavily in clinical monitoring — but what do they actually look for when they evaluate CRA performance? In this session, Leandro draws on his experience from the sponsor side to share what truly distinguishes a great monitor from a good one: the behaviours, mindset, and communication habits that build trust, flag risk early, and make a real difference to trial quality. Whether you're an experienced CRA or early in your career, this session will give you a candid inside view of what sponsors notice, what they value, and what makes them want to work with you again.‍

From Site Selection to First Patient: How CRAs and SSU Teams Can Work Better Together

Study start-up and clinical monitoring are two sides of the same coin — yet the handover between SSU teams and CRAs remains one of the most common sources of friction, delay, and miscommunication in trial delivery. In this session, Laura Van Vaeck goes behind the scenes of the study start-up process to give CRAs a rare inside view of what SSU teams actually do, what they need from monitors, and where collaboration most often breaks down. Drawing on her hands-on experience leading regulatory and start-up operations, Laura will share practical insights on how both roles can align earlier, communicate more effectively, and set each other up for success — from site selection all the way through to first patient in.

Coffee Break & Networking

The CRA Role in 2026: Are We Ready for What’s Next?

As clinical trials evolve, so does the CRA role. This panel brings together senior clinical operations leaders to discuss how oversight, expectations, and required competencies are changing — and whether organizations and CRAs are ready for what lies ahead.

The CRA Mindset Shift: From Monitoring Details to Recognizing Patterns Across the Study

The updated ICH E6(R3) guideline is not asking CRAs to complete more tasks — it is asking them to think differently. In today’s monitoring reality, where documentation, platforms, and operational pressure continue to increase, important signals can easily become lost in detail. This session explores the mindset shift from focusing on isolated findings to adopting an oversight perspective — recognizing patterns, understanding interconnections, and seeing the broader impact across the study. By moving from monitoring details to oversight thinking, CRAs can strengthen risk recognition, avoid unnecessary escalation, and focus their attention where it truly matters for patient safety and data integrity.

The CRA of Tomorrow: How ICON Is Redefining the Role of the Site Expert

The CRA role is evolving — and the industry's hiring expectations are evolving with it. In this session, Nacho Solans Serrat shares ICON's vision for the future of clinical monitoring, exploring how the role is shifting from traditional source data verification towards a more holistic, site-expert model. What does this mean for how CRAs are selected, developed, and evaluated today? And what skills, mindset, and capabilities will define the monitors who thrive in the next chapter of clinical research?

Lunch Break

Beyond SDV: The soft skills that define great CRAs

Focusing solely on the checkbox (SDV) is no longer enough. In this panel, experienced clinical leaders discuss the soft skills that now sit at the core of effective monitoring and oversight — the skills that empower CRAs to think critically, support sites proactively, manage complexity, and add real value beyond data review.

AI Tech vs Human Insight: Can They Coexist in Monitoring?

As technology plays an increasingly central role in clinical monitoring, CRAs are asked to balance digital tools with human judgment and experience. In this panel discussion, technology leaders and former CRAs explore where tools truly add value, where human insight remains irreplaceable, and how CRAs can use technology without losing oversight, context, and critical thinking.

Prevent, Detect, Respond: Mastering Risk and Integrity in Clinical Trials

What if risk management in clinical trials was not about reacting faster — but about thinking differently from the start? In an environment where complexity, data volume, and operational pressure continue to grow, traditional monitoring approaches are no longer sufficient. The future belongs to teams that can anticipate risk, detect weak signals early, and act decisively before issues escalate. This session will challenge the conventional view of the CRA role and clinical oversight, exploring how centralized monitoring, critical thinking, and a culture of ownership can transform how we safeguard trial integrity. It will also address how to respond effectively when risks materialize, including the management of serious breaches, misconduct, and potential fraud, while safeguarding trial integrity. Participants will leave with a clearer understanding of how to elevate their role in risk oversight and contribute to more resilient, high-quality clinical trial delivery.

Coffee Break

The Hidden Cost of Being a CRA: Burnout, Balance, and Emotional Reality of CRAs

We talk about monitoring visits and data quality, but rarely about the toll this work takes on the people doing it. This candid panel discussion opens up the conversation about CRA burnout, work-life balance in a travel-heavy role, and the emotional reality of being the person in the middle. It's time to acknowledge what we all know but rarely say out loud.

Decentralized Clinical Trials: Overcoming Challenges and Embracing Opportunities in Supporting Investigators and Patients

Decentralized clinical trials are reshaping how studies are designed, conducted and experienced — by sponsors, sites, investigators and patients alike. But what does this shift mean for the CRA? In this session, Cristina Florescu draws on over two decades of clinical research experience to explore the practical realities of DCTs: the opportunities they create for more flexible, patient-centred monitoring, and the challenges they introduce for oversight, communication and quality assurance. Attendees will leave with a clearer understanding of how to navigate the evolving landscape of decentralised research and strengthen their role as the connective thread between sponsors, sites and patients.

Day 1 Closing Remarks

Drinks & Networking