Archives: Agenda

• Overviewing emerging trends and the current clinical data landscape to understand how organisations are adapting to increased trial complexity
• Looking at the biggest operational and technology challenges and exploring practical solutions
• Understanding expectations from data teams will be over the next 3–5 years to ensure your team is prepared

Panel seat reserved for event sponsor

• Understanding the key changes introduced in ICH E6(R3) and their impact on clinical research to ensure trial plans are compliant with new regulation
• Understanding new good clinical practice expectations and the connectedness between adopting a risk-based approach
• Looking at practical steps to prepare your team for successful implementation to avoid regulatory roadblocks

• Defining agentic AI and its capabilities to understand how it works and how it differs from automation and rule-based workflows
• Exploring where agentic AI can safely and effectively operate withing regulated environments
• Reviewing real-world use cases and how governance and oversight can enable successful adoption

• Designing a robust clinical data management plan when balancing limited resources
• Weighing up outsourcing versus in house capabilities to support clinical trial plans and stick to timelines
• Ensuring rigorous vendor oversight as a small biotech to ensure regulatory compliance

• Aligning teams to breakdown down silos and encouraging collaboration between different departments to enhance clinical data processes
• Planning early so teams align on clinical data strategy, scope, and expectations
• Establishing clear roles and decision rights across functions to reduce rework and delays

Panel seat reserved for event sponsor