Leading with Vision: How Donna Dorozinsky Balances Innovation and Integrity in Clinical Research Compliance
In an era where clinical trials are becoming more complex and data-rich than ever before, true leadership requires both courage and clarity. At Just in Time GCP, Founder and CEO Donna Dorozinsky leads with both vision and discipline—driving innovation while ensuring every advancement strengthens the core tenets of Good Clinical Practice
Under her leadership, Just in Time GCP has spent more than two decades helping trial sponsors align people, processes, and technology to achieve inspection-ready confidence. But what truly sets Donna apart is her ability to lead through change—empowering others to think differently, experiment safely, and bring innovation to life in one of the most highly regulated environments in the world.
Seeing Beyond Compliance
For Donna, compliance is not a finish line—it’s the foundation for progress. She recognizes that to keep pace with evolving guidance like ICH E6(R3) and the growing digitalization of clinical research, organizations must reimagine how quality and efficiency intersect.
Her vision for Just in Time GCP is grounded in the belief that innovation and compliance are not opposing forces. They are, in fact, complementary. The same rigor that defines GCP should also guide how teams explore, pilot, and adopt new technologies and processes.
“Compliance gives us the framework,” Donna often says. “Innovation gives us the freedom to improve within it.”
Donna put this philosophy into action by investing in a dedicated Innovation department, led by Aaron Grant—a team focused on translating new ideas into compliant, practical solutions that strengthen oversight, streamline processes, and enhance inspection readiness across clinical operations.
Empowering Leaders to Innovate
Innovation can be intimidating. It requires trust—especially when leaders must delegate responsibility for uncharted territory.
Donna’s approach is simple but powerful: hire exceptional people, give them clear direction, and trust them to deliver. By creating space for autonomy within defined guardrails, Donna cultivates an environment where creativity thrives without compromising control. Her leadership team is encouraged to pilot new ideas, learn quickly, and scale what works—translating innovation from theory into measurable impact.
This empowerment model reflects one of Just in Time GCP’s core values: Collaboration. Teams don’t operate in silos—they share insights, challenge assumptions, and align around a common purpose: helping clients achieve inspection-ready confidence through smarter, more efficient processes.
Balancing Innovation with Integrity
For Donna, leadership isn’t about choosing between innovation and oversight—it’s about maintaining the right balance.
She ensures that every initiative, no matter how forward-looking, is grounded in Quality and Integrity. Her approach combines disciplined governance with agile thinking:
- Start small, scale smart: Pilot new approaches within single studies before wider adoption.
- Measure what matters: Focus on completeness, quality, and timeliness as risk signals, not just task completion.
- Integrate, don’t isolate: Align new tools and technologies with established processes and people.
This balanced mindset allows Just in Time GCP to remain both visionary and reliable—a partner that clients can trust to push boundaries without losing sight of regulatory expectations.
Driving Industry Change
Beyond her own organization, Donna is actively shaping the future of clinical compliance. As Editor-in-Chief of Barnett’s Good Clinical Practice: A Question & Answer Reference Guide 2024/2025, she helps translate evolving regulatory expectations into practical guidance for today’s research professionals. She also leads the transformation of the CDISC TMF Standard Model (formerly the TMF Reference Model) and advances education through GCP Directions, ensuring that innovation and compliance evolve hand in hand.
Under her leadership, Just in Time GCP isn’t merely adapting to change—it’s helping lead it. By investing in innovation, fostering collaboration, and applying insights from more than 100 regulatory inspections, Donna continues to guide the industry toward a future where compliance is both rigorous and efficient—and where technology serves its highest purpose: optimizing outcomes for patients.
The Leadership Lesson
True innovation doesn’t come from technology alone—it comes from leadership. Donna Dorozinsky models what modern executive leadership looks like in clinical research: vision balanced with accountability, independence anchored by integrity, and innovation driven by purpose.
At Just in Time GCP, that combination fuels more than transformation—it builds confidence.
Confidence in compliance.
Trust within teams.
And the assurance that progress and quality can coexist—because when they do, patients benefit first.
