A new white paper, Undertaking Phase I Clinical Trials in Australia During a Time of Uncertainty, has been published by Nucleus Network (Nucleus), Australia's largest Phase 1 clinical trials provider. The paper outlines 10 steps to successfully conducting clinical trials in Australia during the current Coronavirus pandemic.

"In the presence of challenges facing our industry as a result of COVID-19, Nucleus is committed to supporting our clients to the highest degree possible to realise their Phase 1 clinical trial aspirations," says Nucleus CEO, Cameron Johnson. "We have developed a comprehensive ten-step action plan to help biotech innovators, pharmaceutical companies, and Clinical Research Organizations, navigate their Phase 1 therapeutic trials through the coronavirus (COVID-19) pandemic."

The 10-step guide is a free resource focusing on conducting phase I clinical trials in Australia and risk mitigation strategies implemented by Nucleus Network. Johnson says the "preparedness of the business to continue providing best-in-class Phase 1 studies, is guided by these 10 pillars:"

1. Multi-site reach in Australia
2. Size, scale and savings
3. World-class medical precincts
4. Social distancing measures
5. Robust participant pipeline
6. Rigorous participant screening
7. Dedicated trial teams
8. Gold standard infection control
9. Cross-functional response team
10. Supply chain surety

Assurance Through COVID-19

Outlined in the white paper is a comprehensive COVID-19 response pack which acts as a source of truth for measures, processes and procedures to respond to the evolving situation.

Importantly, the paper also sets out key risk mitigation strategies implemented by Nucleus Network for undertaking clinical trials.

"Nucleus owns 150 of the total 250 dedicated phase I beds available in Australia over two sites, located within major medical precincts in Melbourne and Brisbane," adds Johnson. "Supported by our workforce of over 400 specialists, we are in the unique position of offering sponsors a multi-site pathway to conduct their clinical trials."

According to Nucleus Network Chief Medical Officer, Jason Lickliter, this Australian advantage is complemented by the calibre of medical staff and attention to every detail within the clinics. "Additional measures implemented by Nucleus Network during the COVID-19 pandemic go above and beyond recommended clinical practices and provide a gold standard in infection control."

For biotech innovators, pharmaceutical companies and clinical research organizations, this is not the time for hesitation. Johnson says it is essential that development of new potential vaccines and therapies continue uninterrupted.

"Our partners and clients are on the frontline of vaccine development, improving the health of communities around the globe with a number of vital drug discoveries. The Nucleus roadmap outlined in this document is a foundation for trial realization and advancement, all within one of the most renowned countries for medical and clinical research excellence."

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