Australia’s First Purpose-Built Regional Phase I Clinical Trials Facility
Australia’s First Purpose-Built Regional Phase I Clinical Trials Facility Opens in Newcastle
On International Clinical Trials Day, local clinical research organisation, Novatrials, marked an historic milestone for regional healthcare with the official opening of its purpose-built Charlestown clinical trials facility.
Located at the Charlestown Healthcare Hub (99 Pacific Highway), the facility is the first of its kind in regional Australia and offers some of the most advanced early-phase clinical trial capabilities in the country.
It was officially opened by the Member for Charlestown, Hon. Jodie Harrison MP.
Novatrials CEO, Amanda Koegelenberg, said the new facility is a gamechanger for the region, for research, and for patient access to life-saving treatments which were traditionally limited to capital cities.
“Our region has a strong track record in clinical trials across public, academic and private sectors, built on experienced clinicians, researchers and strong community participation,” Ms Koegelenberg said.
“We’re proud to extend that capability and provide a dedicated location for enabling early to late stage clinical trials to be conducted right here in the Hunter.”
Bringing Early-Stage Clinical Trials to the Region
Phase I clinical trials are the essential first step in testing new medicinal interventions in humans. These highly regulated, healthy volunteer studies include paid participants who stay overnight at the facility while researchers monitor the safety, dosage, and potential side effects of emerging therapies.
“Becoming a globally recognised region for first of kind clinical trials strengthens our ability to attract future studies and ensures people who need it most can access treatments otherwise unavailable,” Ms Koegelenberg said.
“We can now undertake first-in-human studies here in the Hunter, reducing the barriers for people to participate and helping clinicians stay at the forefront of innovation.”
The Charlestown unit includes 31 overnight beds, an on-site laboratory and pharmaceutical dispensary, consulting rooms, a dedicated infectious disease room, and an infusion lounge, enabling seamless, end-to-end delivery across Phase I to III trials.
Local Research with Global Impact
Novatrials also conducts Phase Ib-III clinical trials across a wide range of therapeutic areas and currently has several exciting studies underway exploring potential new treatments for conditions including skin cancer, weight loss, immune diseases, and mental health disorders.
Each trial contributes to the global development of new, life-changing therapies, and now patients from Newcastle, Lake Macquarie and the wider Hunter can take part in these studies closer to home.
The $5 million investment by Novatrials underscores the organisation’s long-term commitment to innovation, ethical research, and improving health outcomes across regional Australia.
“We’re deeply committed to participant wellbeing, research excellence and community impact,” Ms Koegelenberg said.
“This facility is not just an investment in infrastructure, but in people, science and the future of healthcare in the Hunter.”
