Archives: Agenda

• Why we believe that choosing multiple expert partners on your program is worth the risk
• Why we believe that a focus on expertise pays off in terms of both quality and budget
• What to consider when choosing your partner. How to identify the expert on the market
• How to establish oversight in a multi-vendor environment
• Ensuring sponsor control while partnering with several specialized CROs

During the roundtable discussion session, the conference hall will be divided into three ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Clinical trial applications (CTAs) in Europe

ROUNDTABLE 2
Enhancing collaboration between clinical operations and clinical supply
Marie Rasoanandrasana, Head, Supply Chain and Vendor Management, Debiopharm Group

ROUNDTBALE 3
Navigating geopolitical risks in global clinical trials
Mara Hummel, Associate Director of Global Clinical Operations, Team Leader, Roche

ROUNDTABLE 4
Integrating AI into clinical operations
Constantin Weberpals, Machine Learning Researcher, Former Stanford School of Medicine

• Building trust while maintaining open communication and understanding site needs
• Optimizing monitoring practices
• Using risk-based approaches while ensuring compliance and data integrity
• Streamlining processes while balancing consistency and local flexibility
• Improving engagement while addressing challenges from real-world experiences

• Strategic initial planning and ensuring predictability
• Engagement with vendors, sites, internal and external stakeholders
• Breaking critical pathway and identifying bottlenecks
• Sharing practical tips and best practices for smoother execution

• Engaging patients early in trial design – why timing matters
• Challenges and barriers – what gets in the way of patient engagement
• Practical strategies – how to incorporate patient voices effectively
• Addressing ethical considerations and maintaining trust throughout clinical development

• Adopting RBQM strategies to manage global trial complexity and evolving regulations
• Implementing the Integrated Quality Risk Management Plan to target critical risks
• Defining and tracking QTL Parameters and KRIs to ensure proactive monitoring
• Aligning resource use with risk levels to boost trial efficiency and data integrity
• Learning from Boehringer Ingelheim’s adaptive approach to safeguarding quality and compliance

• Exploring how and why women continue to be excluded from early-phase (Phase I) clinical trials
• Examining the historical, regulatory, and ethical reasons driving this underrepresentation
• Identifying the risks of overlooking sex-based differences in drug metabolism, response, and adverse events
• Assessing how incomplete data is impacting downstream development, post-market safety, and healthcare outcomes
• Promoting actionable strategies for building equity into trial design, recruitment, and data reporting