Where Clinical & Quality Meet: Aligning Operations for Trial Success
Session details:
Clinical trials succeed when quality isn’t an afterthought—it’s integrated from day one. In this panel discussion, clinical and technology leaders will explore how trial management - when approached from a risk-based quality mindset - can reduce risk, improve inspection readiness, and accelerate timelines. Hear real-world insights from both sponsor and CRO perspectives on building proactive, cross-functional practices that work. We will discuss:
- How clinical operations and quality teams can work together—not in silos
- Balancing speed and compliance: strategies for maintaining GCP without slowing down
- Lessons learned from audits, inspections, and deviations that could have been avoided
- Building scalable processes across sponsors and CRO partners
- The role of connected systems (eTMF, QMS) in enabling visibility and accountability
- Cultural and organizational shifts that support quality-driven trial execution
Key Takeaway:
Quality is not a checkpoint—it’s a mindset. When clinical and quality teams align early and often, they create a stronger foundation for trial success.
Interesting Statistic:
💡 Nearly 70% of FDA clinical trial inspection findings are tied to documentation and procedural gaps that could be prevented with better operational coordination.