Nucleus was founded in 2003 as Victoria’s only Early Phase Clinical Trial Facility. Since its inception, Nucleus Network has maintained high standards of clinical governance and safeguards to protect participants, while achieving world class quality standards for sponsors of Early Phase Clinical Trials.
As a dedicated Early Phase Clinical Trials expert, Nucleus Network has grown to become Australia’s leading facility attracting global sponsors from North America, Europe, Asia and across Australia and New Zealand.
The organisation’s values of Trust, Integrity, Excellence and Collaboration have come to underpin its success – Nucleus Network can always be trusted to deliver high and reliable performance levels, with a highly professional team of people that go the extra mile to exceed expectations.
We are Australia’s largest, dedicated Early Phase Clinical Trials expert with unparalleled expertise in the conduct of more than 500 Early Phase Clinical Trials in both healthy and special patient populations, across all major therapeutic areas. With high independent audit performance, our global clients trust our robust quality assurance systems and world class data compliance, knowing we’ll always go the extra mile to exceed their expectations.
Australia’s regulatory environment uses the Clinical Trial Notification (CTN) process, allowing rapid approval by local HREC/ IRB of clinical research sites to conduct early phase clinical trials. An IND submission is not required prior to commencing the trial, even for First Time in Human or proof of concept studies.
At Nucleus Network, all clinical research is conducted in accordance with ICH GCP Guidelines, with all clinical data generated acceptable to the US FDA and European EMEA standards.
Nucleus Network is Australia’s clear market leader in Early Phase Clinical Trials, having completed over 500 trials over the last 15 years. We have extensive experience in evaluating small molecules and biologics in both healthy volunteer and patient populations for all kinds of early stage clinical trials, including exploring novel or new routes of molecule administration.
Trial experience includes: