Archives: Agenda

• 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

• Are we making the most of Technology & Innovation in the Clinical Trial space?
• How are these tools being utilized efficiently?
• The importance of exploring ethical considerations.
• Examining the relationship between innovation, creativity, and regulations
• What’s next?

Interactive session with audience engagement.

Focusing on advancing women’s health and meeting unmet needs

• Patient-reported outcomes (PRO), are becoming more prevalent in trials, often collected by a phone App
• While PRO can increase subject engagement, these data are subjective and cannot support regulatory approval alone
• By understanding the relationships between objective and subjective data endpoints (cortisol level to stress, glucose to Oxygen levels to activity, etc.), trial designers can balance “hard” and “soft” data points.
• These can be collected, analyzed, and presented to regulatory bodies so that data streams support one another, increasing likelihood of regulatory approval for the product.