Ultraclinical is a clinical and commercial consulting services firm purpose-built for the clinical research industry. We work with two distinct client groups, biotech sponsors navigating the complexities of clinical development, and clinical research service providers looking to grow and optimize their offerings in a competitive market.
About Us
What sets us apart is an intimate, on-the-ground knowledge of the clinical research landscapes across Australia, New Zealand, and the United States.
We know the sites. We know the investigators. We understand the regulatory pathways, the nuances of each market, and what it takes to run efficient, high-quality studies in each region. This isn't knowledge built from a distance, it comes from decades of working directly within these ecosystems, helping early-stage US biotech companies access ANZ's world-class research infrastructure for first-in-human studies, and guiding those programmes back to the US for proof-of-concept trials.
This end-to-end, cross-border perspective means we understand the operational, regulatory, and strategic challenges that arise at every stage of early clinical development. We don't just advise, we draw on real experience of navigating these journeys ourselves.
At Ultraclinical, our mission is simple: to be the trusted partner that helps our clients move faster, smarter, and with greater confidence - wherever their clinical programme takes them.
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Our Services
Clinical Consulting
At Ultraclinical, we partner with sponsors and research organizations to bring clinical trials to life with confidence and precision. Our experienced consulting team provides end-to-end support across the full study lifecycle — from early-stage planning through to regulatory submission.
We offer feasibility support across Australia, New Zealand, and the United States, helping you identify the right sites, assess patient populations, and evaluate operational timelines to set your study up for success from day one. Our RFP development services ensure your study requirements are clearly defined and compellingly communicated to CROs and site partners, driving competitive and accurate proposals.
Explore our range of comprehensive consulting services designed to address your specific business needs and drive sustainable growth
Therapeutic Areas
With over 30 years of experience and hundreds of sponsors supported across that time, Ultraclinical brings a depth and breadth of therapeutic knowledge that is genuinely rare in clinical consulting. Our team has worked across a wide spectrum of disease areas and modalities, giving us the cross-functional insight to anticipate challenges, ask the right questions, and deliver solutions that are grounded in real-world clinical trial experience.
Our therapeutic expertise spans immunology, autoimmune conditions, dermatology, ophthalmology, cardiology, endocrinology, hepatology, gastroenterology, pulmonology, and neurology encompassing both common and rare disease indications across adult and paediatric populations.
Clinical Consulting Services
When it comes to study design, our critical protocol review provides an expert, independent assessment of your protocol, identifying gaps, inconsistencies, and opportunities to strengthen scientific integrity and operational efficiency before you go to sites. Our medical review capabilities offer ongoing clinical oversight throughout the trial, ensuring safety signals and data integrity are managed with rigor and care.
We also provide tailored recruitment and retention strategies to keep your trial on track and on time. From patient identification and referral pathway development through to engagement initiatives that support participants throughout their study journey, we help sites reduce screen failure rates, minimize dropout, and meet enrollment targets without compromising data quality.
Backed by deep regulatory expertise, we provide practical guidance across ICH, TGA, Medsafe, and FDA frameworks, helping you navigate complex submission requirements and regulatory strategy with clarity.
Whether you're launching a first-in-human study or scaling a global programme, Ultraclinical delivers the specialist expertise to move your trial forward, efficiently, compliantly, and with the highest standard of clinical excellence.
Feasibility support across Australia,
New Zealand, and the United States
Helping you identify the right sites, assess patient populations, and evaluate operational timelines to set your study up for success from day one.
RFP Development, Critical Protocol Review, and Medical Review
Ensure your study requirements are clearly defined and communicated to CROs and site partners. Identifying gaps, inconsistencies, and opportunities to strengthen scientific integrity and operational efficiency before you go to sites. Provide ongoing clinical oversight throughout the trial, ensuring safety signals and data integrity are managed with rigour and care.
Recruitment and Retention Strategies, Backed By Deep Regulatory Expertise
Keep your trial on track and on time. We provide practical guidance across ICH, TGA, Medsafe, and FDA frameworks, helping you navigate complex submission requirements and regulatory strategy with clarity.
Therapeutic Areas
Our therapeutic expertise spans immunology, autoimmune conditions, dermatology, ophthalmology, cardiology, endocrinology, hepatology, gastroenterology, pulmonology, and neurology encompassing both common and rare disease indications across adult and paediatric populations.
MODALITIES
We have extensive experience across a broad range of modalities, including small molecules, biologics, monoclonal antibodies, gene therapies, cell therapies, and advanced therapeutic medicinal products (ATMPs), allowing us to engage meaningfully with complex and novel development programmes from the outset.
EXPERTISE
With experience spanning first-in-human Phase 1 through Phase 3 trials, we help you navigate from preclinical to the clinic, always thinking about how your protocol will translate operationally. Because a well-designed study on paper still has to work at the site level.
SUPPORT
Whatever your indication or development stage, Ultraclinical has the experience to support you with confidence.
MEET OUR TEAM
Alyce King, Managing Director
Alyce has built her career on something she believes deeply: that the best clinical partnerships start with real relationships and genuine trust. With over 15 years of experience across CRO, biotech, and healthcare, she brings to Ultraclinical LLC not just a strong commercial track record, but a true passion for connecting innovative companies with the right people and vendors to help them succeed.
Prior to co-founding Ultraclinical, Alyce spent nearly nine years at a global CRO, where she was personally selected by the CEO to relocate from Sydney to Boston and establish their East Coast US office. Her mission was to build relationships within the US biotech community and introduce emerging companies to the advantages of conducting early-phase studies in Australia and New Zealand. During her time she watched the company grow from ~200 to over 3,000 employees, a journey she was privileged to be part of from the very beginning of its international expansion.
Early in her career Alyce led a commercial team at Australia's largest pharmaceutical and medical device distributor, managing complex national partnerships across hospitals, pharmacy, aged, primary, and community care, work that sharpened her instinct for navigating high-stakes negotiations with focus and precision.
Alyce holds a Bachelor of Science in Chemistry and Physiology from Monash University, a foundation that means she can sit across the table from a scientist and have a real conversation, not just a commercial one.
Ultraclinical LLC is where all of that comes together. For Alyce, it's an opportunity to work closely with the sponsors she believes in, and to build the kind of long-term relationships that make a genuine difference.
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Donna Fraser, Managing Director
Donna Fraser has spent over 30 years doing work she genuinely loves, supporting the development of treatments that make a real difference in people's lives. As a Registered Nurse by training, she came to clinical research the long way around, with 13 years of hands-on patient care across New Zealand and the United States that still shapes the way she thinks about every trial she touches.
For Donna, drug development has always been personal. That clinical foundation carried her into a 20-year journey with a full service CRO, where she grew alongside the organization as it expanded from its Asia-Pacific roots into a globally recognized full-service CRO. Along the way she held senior roles across Clinical Operations in Australia, New Zealand, and eventually the United States, building deep relationships with sponsors, sites, and teams that have followed her throughout her career. Donna has worked closely with biotech and pharmaceutical sponsors at some of their most critical moments in their development programs, offering the kind of honest, experienced guidance that comes from genuinely caring about the outcome.
Her areas of focus include dermatology, cardiology, ophthalmology, neurology, immunology, medical devices, and rare diseases, complex areas where relationships with the right sites and investigators make all the difference. Ultraclinical LLC is the natural next chapter, a place where Donna can work closely with the sponsors and teams she believes in, with the time and focus to do it right.
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Dr. Bruce L. Davidson, MD, MPH – Medical Advisor
Dr. Davidson is a distinguished Board-Certified Pulmonologist and Critical Care Physician with nearly five decades of expertise in Pulmonary and Critical Care Medicine. A respected clinician, researcher, and Internal Medicine educator, he brings a rare combination of deep clinical knowledge, academic rigor, and public health insight to every engagement.
Throughout his distinguished career, Dr. Davidson has served as a Pulmonary and Public Health Physician while maintaining active involvement in clinical research, journal publication, and medical education. He has sat on numerous Scientific Advisory Boards, continues to review and publish in peer-reviewed journals, and remains a committed advocate for advancing best practices in respiratory and critical care medicine.
Education & Training
• Medical Degree: Lewis Katz School of Medicine at Temple University (1977)
• Residency: University of Texas Southwestern Medical Center and University
of Pennsylvania Medical School
Areas of Specialization
• Pulmonary Medicine & Critical Care • Public Health & Epidemiology • Clinical Research & Protocol Development • Internal Medicine Education • Scientific Advisory & Peer Review