Archives: Agenda

Key Topics Covered:

• Introduction to the Transformative Landscape: Overview of how AI, ML, and RWD are fundamentally changing the structure and execution of clinical trials.
• Advanced Trial Design & Digital Integration: Detailed discussion of Federated HER platforms and eSource-supported trials, showcasing their impact on operational efficiency and trial accuracy
• AI-Driven Patient Recruitment Strategies: Exploration of unstructured data integration (clinical notes, lab reports) and its role in precise patient identification and accelerated recruitment timelines.
• Case Studies and Real-World Applications: Presentation of practical examples, including AI-driven recruitment solutions for pharmaceutical trials and data quality improvements within the European Health Data Space (EHDS).
• Outlook and Future Developments: Insights into emerging trends, such as increased cross[1]border collaboration, patient-centric approaches, and the evolution of AI applications in enhancing trial efficiency and global healthcare outcomes

• Defining high-fidelity synthetic data
• MHRA approach to synthetic data generation
• Can synthetic data be used to validate ML algorithms?
• Can synthetic data be used for sample boosting?
• Can synthetic data address biases due to underrepresentation?
• Can synthetic data be used to enhance clinical trials (CTs)?
• Regulatory considerations

• Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
• Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
• Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
• Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

Small biotech companies often face unique challenges when conducting Phase 1 clinical trials due to limited financial and human resources. This session will explore practical strategies and tools that can help these companies effectively manage their trials while navigating regulatory requirements. Attendees will gain insights into optimizing trial design, budget management, and leveraging partnerships.

• Understand the financial challenges faced by small biotech companies in running Phase 1 trials.
• Explore strategies for effective resource allocation and cost management in clinical trials.
• Learn about tools and technologies that can streamline trial operations and improve efficiency.
• Discuss regulatory considerations and compliance best practices that impact trial management.

This session will explore the principles, methodologies, and tools of Risk-Based Quality Management (RBQM) in clinical trials. It will focus on how a risk-based approach can enhance compliance, improve data quality, and optimize trial efficiency. Attendees will gain practical insights into risk assessment, monitoring, and mitigation strategies, with a particular emphasis on implementing RBQM frameworks in alignment with ICH E6(R3) guidelines.

• Overview of RBQM: Concepts and Regulatory Frameworks
• Designing a Risk Assessment and Categorization Tool (RACT)
• Centralized and On-Site Monitoring Strategies
• Leveraging Technology for Risk Management
• Case Studies: Lessons Learned from Implementing RBQM
• Future Trends and Updates in Regulatory Guidance