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."


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

semi circle of dots, and just in time gcp logo

In Their Words

"Attending the Beyond Clinical Conference reaffirmed my passion for quality by reminding me of key historical lessons, practical tools to improve efficiency, and the challenges we strive to overcome to make meaningful impact within our organizations."


"The Beyond Clinical Compliance conference was one of the most engaging and interactive that I have experienced."


"Attending was a strategic investment, offering a pulse-check on industry trends and equipping the audience with practical knowledge to enhance our inspection preparedness."


"Kristen, you are a great organizer who understands the topics and what is 'hot' - I appreciate these events much more than larger ones, and I have heard others onsite echoing the same thing!"


"Engaged, passionate, helpful topics and conversations with Clinical Quality experts and enthusiasts."


"Perfect industry update on current experiences with regulatory inspections in a concise and focused setting, easily worked into the work week."


"Kristen is building a community to exchange relevant Clinical Quality information in an intimate, pleasant and collaborative setting."


"This conference provides a productive forum for quality professionals to engage, benchmark, and validate quality management needs as they apply to different life science organizations and development programs."


"Engaged in thought-provoking discussions at the conference, exploring forward-thinking strategies to strengthen risk management, quality, and innovation in clinical development."


"Attending reaffirmed why collaboration matters in clinical research."