Agenda Archive

PANEL DISCUSSION Enhancing site engagement and monitoring, strengthening site relationships

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

Moderator

Sonnika Lamont, Senior Analyst, GlobalData

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

Moderator

Sonnika Lamont, Senior Analyst, GlobalData

Case studies demonstrating use of AI, predictive analytics and data-driven approaches to increase the likelihood of technical and regulatory success and to execute with greater speed and accuracy
Mitigating risks across the trial lifecycle to improve efficiency and outcomes
Streamlining operations to meet rising demands for faster, more cost-effective, and compliant trial
Harnessing site- and patient-level intelligence to enable smarter patient and site-centric protocol design and improved study performance