Nor Consult, LLC - Excellence in Clinical Research - Expertise

Expertise

Our Approach

Direct Access to Senior Expertise

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  • At Nor Consult, our clients work directly with senior scientists, biostatisticians, and clinicians. Every engagement is guided by experts in biostatistics, regulatory affairs, and clinical operations, ensuring trials are designed and executed with precision.

    Sponsors benefit from direct access to leaders who combine academic rigor with industry-tested experience.

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Primary Therapeutic Areas

Focused Expertise in Critical Therapeutic Areas

At Nor Consult, we specialize in high-stakes clinical trials across critical therapeutic areas, delivering outcomes regulators and payers demand.

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    Cardiovascular

    Cardiovascular

    Driving innovation through reliable, end-to-end clinical research support.

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    Spine & Orthopedics

    Spine & Orthopedics

    Driving innovation through reliable, end-to-end clinical research support.

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    Neurology & CNS

    Neurology & CNS

    Driving innovation through reliable, end-to-end clinical research support.

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    Wound & Infectious Disease

    Wound & Infectious Disease

    Driving innovation through reliable, end-to-end clinical research support.

Client Success Stories

Device & Drug Dual Strength

NOR Consult integrates both device and drug expertise, aligning trial design with regulatory, payer expectations and clinical adoption in one integrated strategy.

  • Device Category Expertise

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    Guiding device trials from concept to approval across IDE, PMA, 510(k), and De Novo pathways.

    • IDE, PMA, 510(k), De Novo submissions

  • Pharma Category Expertise

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    Expertise in Phase 2–3 trials, safety reporting, DSMBs, and payer readiness for successful drug development.

    • Phase 2–3 trials, DSMBs, safety reporting, payer readiness

Experience Matters – Proven Expertise Across Devices and Drugs

Trusted Minds

Meet the Experts

At NOR Consult, we specialize in high-stakes clinical trials across critical therapeutic areas, delivering outcomes regulators and payers demand.

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    Branko Kopjar, MD, MSc, PhD, FACE, FAcadTM

    Founder & Managing Member

    I founded Nor Consult, LLC in 2005 with a clear vision: to bring rigorous science and practical wisdom together so that innovators in life sciences can deliver meaningful therapies to patients.

    My career has been a journey through many roles, including professor, biostatistician, clinical epidemiologist, government advisor, and industry consultant. Each role gave me a different lens on the challenges of developing new therapies, and together they inspired me to create Nor Consult. My goal was to create a consultancy that brings together academic rigor and real-world experience, turning complex data into clear strategies that drive innovation and improve patient outcomes.

    Two decades later, I’m proud of our collaborations with start-ups and global leaders alike, driving First-in-Human and pivotal studies, securing key regulatory approvals, and advancing therapies that change patients’ lives.

    In addition to my role at Nor Consult, I serve as an emeritus faculty member at the University of Washington, where, since 1997, I have led research in clinical epidemiology, health outcomes, and medical product evaluation. This balance of academic leadership and hands-on industry work continues to shape our approach: scientifically grounded, results-driven, and always focused on patients.

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    Patrick Heagerty, PhD, FASA

    Senior Scientific Advisor

    Patrick Heagerty, PhD, is a Professor, former Chair of Biostatistics and Director of the Center for Biomedical Statistics at the University of Washington. He is nationally recognized for his deep expertise in clinical trial design and advanced statistical methodologies. Nor Consult has a multi-year partnership with Dr. Heagerty supporting our clients across various therapeutic areas, including medical device and cardiovascular trials.

    His leadership roles, including on the FDA Sentinel Innovation Center, highlight his profound understanding of regulatory requirements and best practices in biostatistics. Dr. Heagerty’s guidance ensures robust study design, precise data analysis, and strategic insights crucial for successful clinical development programs.

    Dr. Heagerty holds a BS in Biology from Cornell University, a MS in Statistics from State University of New York (Albany) and a PhD in Biostatistics from Johns Hopkins. He serves as a statistical editor for the Journal of the American Medical Association (JAMA) and is an elected member of the National Academy of Medicine.

Ready to Accelerate Your Clinical Program?

Partner with senior experts who deliver FDA- and EMA-ready data with efficiency and precision.

Meet Our Experts