Archives: Agenda

• Analyzing the specific regulatory challenges posed by the IVDR for rare disease studies and the implications for trial design and execution
• Exploring the crucial role of diagnostics in rare disease clinical trials, including their use for patient stratification, biomarker identification, and treatment assessment
• Addressing the need for streamlined processes and collaborative efforts to reduce the burden on test development for diagnostics used in rare disease studies, ensuring efficiency and compliance

• Discussing the impact of eligibility criteria and small patient population
• Exploring innovative approaches to recruit eligible participants, including leveraging digital platforms and social media outreach
• Highlighting the significance of collaboration between researchers, clinicians, patient advocacy groups, and regulatory bodies in overcoming enrollment challenges
• Strategies for navigating the complexities of rare diseases to ensure accurate diagnosis, patient identification, and enrollment
• Maintaining integrity in clinical trials and risks of premature publicity

• Patient consent
• Patient safety and clinician accountability
• Data privacy, HIPAA, 21 CFR Part 11 and related guidelines and regulations
• Bias
• Education and research implications

This presentation will highlight.

• Ensuring that KPIs are informative and meaningful.
• Assessing overall project risk and appropriate surveillance tactics
• Consolidating your overall management strategy that can be coordinated with CRO SOPs
• Providing documentation of Sponsor oversight activities throughout the study

• Strategies for Country and Site Selection
• Optimizing cost and time
• Large and small company perspectives
• Leveraging global trial footprint to accelerate clinical development
• The evolution of Clinical Development in AsiaPacific
• How different notified bodies and their regulations present challenges to our clinical execution strategies