Brisbane • Melbourne • Minneapolis
With locations in Brisbane, Melbourne and Minneapolis our international footprint covers a population of over 11 million people across all three sites, and provides us with the ability to offer a multi-country and multi-site solution for the conduct of early phase clinical trials.
Whilst Australia continues to be recognized globally as a destination of choice for early phase clinical trials, we also recognize that Australia is not always the solution for every Biotechnology and Pharmaceutical company.
As the only Phase 1 clinical research organization with Phase 1 facilities in Australia and the USA, Nucleus Network has the regulatory and clinical expertise in both Australia and USA to assist clients in determining the most appropriate clinical trial strategy, as well as being able to execute that strategy in either our Australian or our USA Phase 1 facilities.
Nucleus Network has the regulatory and clinical expertise in both Australia and USA to assist clients in determining the most appropriate clinical trial strategy.
Through our multi-site and multi-state Phase 1 facilities, Nucleus Network can simultaneously recruit patients across two of Australia’s largest major cities, making it an ideal strategy for first in human umbrella study designs and significantly reducing patient recruitment timelines.
This can all be achieved through a single approval process. The combined population of 7.5 million people across the cities of Melbourne and Brisbane also significantly de-risks large scale early phase clinical trials (i.e biosimilars), where one Phase 1 facility can be initiated as the primary site and the other Phase 1 facility as a secondary site.
Australia continues to build its reputation as a country of choice for the conduct of early phase clinical trials. With a streamlined regulatory approval process for clinical trials, where an IND is not required to have been opened in the USA, world-class quality standards and favorable foreign currency exchange, Australia provides many advantages to Biotechnology and Pharmaceutical Companies.
For Pharmaceutical and Biotechnology companies searching for the most expeditious path into first in human clinical trials, Australia offers one of the fastest regulatory approval processes in world. The distinct advantage for Australia is that no IND is required to commence clinical trials. Upon completion of pre-clinical studies, Pharmaceutical and Biotechnology companies can achieve clinical trial approval in Australia within 4-5 weeks of Nucleus Network receiving the Protocol and Investigators Brochure.
Clinical trial data generated in Australia (including first in human clinical trial data) is acceptable to the USA FDA, EMA, PMDA and Health Canada Regulatory Bodies. Australia is well known for its highly skilled workforce, world class medical expertise and compliance with ICH GCP guidelines. Data generated in Australia is typically utilized to support regulatory filings and Nucleus Network has experienced FDA (505b2, ANDA, Biosimilar) EMA (Biosimilar) and ANVISA inspections.
Due to foreign currency exchange, conducting Phase 1 clinical trials in Australia can be 20%-30% cheaper than the USA. There is also a Research and Development (R&D) Tax Scheme in Australia, where eligible companies can access a 43.5% cash refund for R&D activities undertaken in Australia (including clinical trial costs). These factors can contribute to an overall clinical trial cost saving of 60%-70% compared to conducting the same study in the USA.
Our Minneapolis facility is one of the very few specialized Phase 1 units capable of delivering patients for Phase 1 hepatic and renal clinical trials in the USA. The facility has highly valuable specialized patient recruitment capabilities, including onsite dialysis capabilities for severely impaired patients. These capabilities combined with a large college student population make this Phase 1 facility ideal for standalone patient studies or first in human umbrella protocol designs.
Nucleus Networks Minneapolis Phase 1 facility (formerly Prism Research) has long-term partnerships with private clinicians and specialty groups for conducting early phase patient studies. With over 15 years’ experience in executing hepatic and renal clinical trials in mild, moderate and severe patient populations for NDA submission, Nucleus Network patient recruitment extends into various other therapeutic areas as well as healthy volunteers.
Strategically positioned in the epicenter of the life science hub of Minnesota and centrally located between the Twin Cities makes for an ideal location to maximize geographic and demographic resource, allowing ease of access for entire St. Paul / Minneapolis metro areas and a five-mile proximity to four private colleges. It is also the only Phase 1 facility in the State of Minnesota.
With Phase 1 facilities in the USA and Australia, we can provide Pharmaceutical and Biotechnology companies with unbiased expertise toward your strategy. Nucleus Network can either execute your first in human study under an IND in the USA or in Australia without an IND. For umbrella / adaptive protocol designs of patient populations, a combination of the USA and Australia is a unique offering.