Where Clinical & Quality Meet: Aligning Operations for Trial Success

Wed, Oct 8 | 09:45 AM - 10:15 AM

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. 

Tracks:
Clinical Quality
Community:
Clinical