This session explores the early protocol decisions that most strongly shape trial execution and the operational principles that matter most. Using real-world protocol scenarios as the anchor, it will examine how seemingly small design choices can create or prevent major downstream complexity
- How the same protocol can lead teams in very different operational directions
- Where small ambiguities become big execution problems
- Which protocol elements deserve the closest scrutiny before build begins
- How aligning design and operations early ensures readiness and reduces risk
Gain insights from a Clinical Trials Global Regulatory Lead on navigating the evolving global regulatory landscape, from early development through to submission readiness.
- Anticipating regulatory expectations and aligning strategies early in development
- Integrating regulatory perspectives across Phase I–III to streamline approvals
- Common challenges and proactive approaches in global filing preparation
Why the oversight of CROs need an evolution
- Transforming Role of the CRO: from vendor to strategic allies
- Changing mindset from sponsor holds risks to sharing risk approach
- Implementing the change in various types of trials
- Overview of outsourcing models: Full-Service Outsourcing (FSO), Functional Service Provider (FSP), and in-house
- Pros and cons of each model and how to select the best fit for your trial
- When hybrid approaches (mixing outsourcing and in-house) are more effective than fully outsourcing or keeping trials fully internal
- Understanding why FSP is gaining popularity among sponsors and how it can help meet trial timelines
Moderator: Sonja Weiser, PhD, Senior Director, Clinical Operations, Insmed Germany
