Archives: Agenda
Accelerating study start-up: breaking bottlenecks and enhancing predictability
- 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 clinical development for enhanced clinical trial outcomes
- 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
CASE STUDY Reimagining clinical trial oversight through risk-based quality management
- 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
Afternoon refreshments and networking
PANEL DISCUSSION Bridging the early-phase divide: advancing equity by including women in drug development
- 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 |
AI-Powered trials: transforming design and execution
- 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
Morning refreshments and networking
Registration and refreshments
FIRESIDE CHAT Establishing and expanding registries for global impact
- Understanding the purpose and value of registries in healthcare
- Setting up new registries from design to implementation
- Collaborating with existing registries for data integration and efficiency
- Developing an umbrella approach for local teams to connect under a global protocol
- Defining key operational aspects
- Determining registry duration and appropriate patient enrollment numbers
- Identifying opportunities for continuous improvement and innovation in registry operations
| Moderator
Sonnika Lamont, Senior Analyst, GlobalData |