A candid conversation with David Kelleher, CEO 4G Clinical

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As clinical trials become more complex, the margin for error in trial supply continues to shrink. Protocol amendments are now routine, not exceptional, and supply strategies must absorb change without compromising patient safety or study integrity. In this interview with Onyx, David Kelleher shares how 4G Clinical has approached this reality from day one, designing systems and operating models around a simple premise, failure is not acceptable.

The conversation explores how value in trial supply management has shifted over time. What once centered on speed at startup is now defined by flexibility mid-study, supply chain efficiency, and the ability to respond to change without disruption. Rather than optimizing for best-case scenarios, 4G Clinical has focused on building technology that assumes change and holds under pressure.

Dave also speaks candidly about AI. In an industry that is rightly risk-averse, 4G Clinical is taking a measured but intentional approach, focusing on applied AI that solves real problems, with human oversight and validation built in. The emphasis is not AI for its own sake, but careful application where it improves accuracy, efficiency, and reliability.

Key themes from the discussion

• Execution without compromise - How the technology is built to safeguard randomization, dosing continuity, and study integrity throughout the trial.

• Value delivered across the study lifecycle -  How value has shifted from rapid startup to long-term supply chain efficiency, waste reduction, and operational resilience.

• Flexibility as a requirement -  Why mid-study protocol amendments now drive technology decisions, and how clinical supply considerations must adapt in real time without delaying progress.

• AI with clear boundaries -  How AI is approached with intent and discipline, with human oversight built in.

• Consistency at a global scale -  How a truly global team stays aligned to purpose while executing consistently on a global scale.

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About 4G Clinical
4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) to accelerate clinical trials. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. Learn more at www.4gclinical.com. 

Press Contact:
Libbi Rickenbacher
marketing@4gclinical.com