Gap analysis and clinical services to strengthen your study design

Moving from preclinical studies to first-in-human (FIH) trials is a pivotal step in any drug development program. But too often, sponsors face avoidable delays due to data gaps, protocol misalignment, or unclear regulatory expectations.

At Nucleus Network, we’ve seen how early, expert input can make the difference. That’s why we offer a complimentary Preclinical Gap Analysis, designed to ensure your package is aligned with Human Research Ethics Committee (HREC) requirements before submission.

Led by our Chief Medical Officer, Dr. Jason Lickliter, and Chief Scientific Officer, Dr. Graham Wood, this service gives sponsors the clarity and confidence needed to move forward with fewer surprises and stronger submissions.

Trusted Experts, Proven Process

This isn’t a generic checklist, it’s a personalized review led by two of the most experienced professionals in early-phase research:

• Dr. Jason Lickliter – Over 1,000 HREC submissions led, with deep experience in protocol design and ethics navigation.
• Dr. Graham Wood – Specialist in preclinical and clinical pharmacology, focused on aligning trial strategy with regulatory and scientific expectations.

Combined with the expertise of Nucleus Network’s clinical and scientific teams and unified global operations across Australia and the U.S., the Gap Analysis reflects our commitment to helping sponsors move with speed, clarity, and confidence from preclinical alignment to first patient dosed.