Beyond Clinical Compliance - May 12-13, 2026
Risk, Quality and Innovation in the R3 Era
Highlights from September 2025
Our inaugural Beyond Clinical Compliance brought together senior leaders across pharma, biotech, and service providers for two days of real conversation and practical strategies.
What made it special:
- A standing-room keynote from Tyler Shultz, Theranos whistleblower, on integrity in clinical research.
- Interactive panels on TMF oversight, vendor qualification, and R3 implementation.
- Small group formats that made it easy to connect 1:1.
- ** candid inspection gossip session** where participants shared lessons learned in real time.
- 65% of attendees had 15+ years’ experience, creating a peer group with deep expertise.
Featured Sessions
KEYNOTE—When Quality Fails Quietly: A Cautionary Tale from Inside Theranos
Tyler Shultz, Scientist, Entrepreneur & Whistleblower
FDA IN TRANSITION
Understand the Recent Changes in the FDA and Impacts to Oversight and GCP Inspection Readiness
Niloy Shah, Executive Director, Research & Development Quality, REPLIMUNE
ALIGNING PROCESSES FOR R3
How to Prioritize Updates So Your Clinical Team Doesn’t Waste Time or Miss Critical Risks
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
2025 Lead Sponsor
For over twenty years, Just in Time GCP has empowered trial sponsors with inspection-ready confidence . Guided by a commitment to quality and innovation, Just in Time GCP aligns people, processes, and technologies with both regulatory standards and each organization’s unique goals. Through collaboration and forward-thinking strategies, we provide peace of mind that trials are inspection-ready today—and equipped for the challenges of tomorrow. Click here to learn more.
