Australia: reduce PhI costs by 60% & save 6+ months with Scientia Clinical Research
Scientia is Australia’s leading Phase I, Healthy Volunteer Unit and a Not For Profit facility.
We have world-class expertise, unmatched facilities, conduct a wide range of clinical trials and are FDA audited. Our focus is the delivery of Phase I HV studies across a wide range of therapeutic disciplines, including complex oncology and haematology studies.
We are uniquely familiar of the nuances of working with biotech sponsors like yourself and understand that no two biotechs are ever the same. We can help you to take advantage of Australia’s world-leading streamlined regulatory approval system, as well as grants and incentives that attract both pharmaceutical giants and red-hot startups.
- Accelerated pathway to First patient, first dose – the streamlined regulatory pathway in Australia means there is no requirement for an IND and study approval is centralised through our preferred IRB. This allows you to save time and money in your development as study approval is generally 4-6 weeks from IRB submission to outcome and a total start-up period of less than 2 months compared to 6-8 months for US/EU sites.
- Attractive rebates – the Australian Government offers a potential 43.5% cash refund for every dollar spent on R&D activities. Once the lower labour costs, lower patient & site fees and weaker AU dollar are considered, the cost to run a study is generally 60-65% less expensive than running exactly the same study in the US and EU.
- Rapid recruitment in healthy and patient populations – Scientia has access to arguably the cleanest database of healthy volunteers, unmatched infrastructure compared to other units and our unique co-location in a major research precinct means that we have access to participants that are often out of reach to other sites. Coupled with lower patient and site fees, we have a track record of rapid recruitment and can recruit your study 30-35% more cost effectively than other jurisdictions.
- FDA Accepted data – all data generated within our Unit is accepted by the FDA, EMA and other regulators. We have a track record of working with our sponsors to accelerating their PhI and help them pivot into larger PhII/III projects once we have desirable safety and efficacy signals, all without having to redo studies in other jurisdictions.
Scientia has a strong track record of helping small to mid-sized biotechs as they progress through their development, and we have the scale and reach to help you exceed your corporate milestones.
If you are open to considering Australia, we can lead your PhI project to success and as a trusted partner, we bring assets from clinical to commercial and beyond.
For more information please email bdenquiries@scientiaclinicalresearch.com.au
