Archives: Agenda

• Looking at gathered contributions from clinical trial regulators, researchers, civic society and patient groups, pharmaceutical industry, ethicists, funders and many more
• Exploring the key contributors to a successful clinical trial ecosystem to achieve clinical development operational excellence
• Reinforcing global standards in the design, conduct and reporting of clinical trials

Clinical operations in rare disease trials have unique challenges due to small patient populations, limited understanding of the disease, and lack of established clinical endpoints. In this case study, we will explore:

• Adaptive trials designs to adjust clinical protocols based on interim results
• Specialized approaches to managing sponsor and site relationship
• Decentralized trials and leveraging technology to perform remote assessments
• Collaboration with patient communities and others

We may also discuss approaches that we previously employed but concluded as not suitable or too premature for rare disease trials.

• Find out when you can waive the need for Consent Forms
• When needed, ensure that Informed Consent Forms include key information
• Implement decentralized clinical trial elements to improve trial participant engagement, recruitment, enrollment, and retention

• Delving into the transformative impact of AI across the healthcare and life sciences ecosystem
• Exploring how AI technologies are revolutionizing drug discovery, enhancing clinical trial efficiency, and enabling more personalized patient care.
• Streamlining early-stage research and optimizing real-world applications in patient monitoring and therapeutic delivery
• How AI is paving the way for faster, more precise, and impactful healthcare solutions
• Insights into the latest AI-driven innovations and how these advancements are shaping the future of healthcare from concept to patient outcomes