Event Highlights
Clinical research is evolving—and so are the expectations for compliance. Beyond Clinical Complianceis a working conference for quality, operations, and compliance professionals who are ready to think differently about risk, oversight, and inspection readiness in the era of ICH E6(R3).
This event goes beyond frameworks and checklists. It creates space for real conversations and shared problem-solving across roles and organizations. Whether you're managing trials, overseeing vendors, optimizing systems, or building inspection readiness strategies, you’ll leave with actionable insights and renewed focus.
Highlights
RISK TRIAGE IN COMPLEX TRIALS
When Everything Looks Like Risk: How Clinical Quality Teams Can
Triage Oversight in Complex Trials
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
"Everything I needed to know about running a company, working, and clinical research, I learned as an ER Nurse. Because we triage."
"Everything can't be critical. Everything is not an emergency."
"A signal becomes meaningful when you can connect it to something that's impactful."
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CHAMPIONS OF QUALITY
They Built the Culture Behind Compliance: How Quality Leaders Create Environments Where the Right Decisions Actually Happen
"Quality has to start at the top."
"You're hopefully catching a lot of fires that eventually never burn."
"The way that we overcome sponsor/CRO misalignment is through quality agreements, paying for the resourcing we expect, and getting the services we require."
"We're getting better and better at our governance meetings with vendors... building relationships directly with our QA partners and risk management partners."
"The times that I've seen quality decision-making go wrong have been when every decision has to get escalated to every level of leadership."
2026 Lead Sponsor
Past Attendee LinkedIn Posts
