Reduce 70% of the cost of your full GCP FDA-compliant clinical trial
iNGENū is the Australian-based CRO specialized in the FDA regulatory pathway. By using Australia as the research destination, we significantly reduce your costs, while accelerating the startup time to “First-Patient-In” by over 80%.
How do we do it?
You heard right. iNGENū is able to cut 70% of the cost of a full GCP FDA-compliant clinical trial for US biotechs. And we reduce the startup time to “First-Patient-In” by over 80%.
You’re wondering… How do we do it?
We use Australia as the research destination. Australia boasts an unmatched government funding scheme, allowing us to deliver exceptional results for US biotechs, while also magnifying the value of our investments. iNGENū CRO is specialized in the US FDA regulatory pathway.
US-based small to mid-sized biotechs trust iNGENū with their Phase 1 and Phase 2 clinical trials. Over 90% of our sponsors are from North America and use Australian data to submit to the US FDA. And, over 50% of our clients are publicly-listed, including several on the NASDAQ.
CRO industry-leaders in Australia and the world
iNGENū are a full-service CRO, laser-focused on accelerating our US Sponsors through the FDA IND-enabling and early stage clinical trials.
We have significant FDA regulatory experience, with our regulatory affairs team members having a combined experience of over 100 Pre-INDs and dozens of INDs during their careers.
Premium quality clinical trial projects. 70% cost reduction.
iNGENū delivers clinical trial projects at a 70% cost-reduction. In other words, you reduce the amount of capital your firm has to raise by 70% – which is revolutionary.
Fast-track your clinical trial application
Reduce the startup time of your clinical ttial to “First-Patient-In” by over 80%!
So, while you might expect a 9 - 12 month process in the US to perform your IND-enabling studies and open your IND… iNGENu’s Phase I and 2 Clinical Trial applications in Australia typically start recruiting patients within 8 weeks on average.
And, we usually achieve a 4 week IRB/HREC turnaround time, due to Australia’s highly supportive and streamlined ethics processes.
Understand the iNGENū CRO difference
The iNGENu Australian Advantage: How It Works
Our Australian Advantage enables us to deliver proven, market-leading CRO services to US biotech companies at a 70% cost reduction, and a 90% reduction of elapsed time.
R&D Tax Incentive of 43.5%: A Global Leader
Australia’s Research & Development (R&D) Tax Incentive of 43.5% provides a rebate for all R&D expenses. This figure is considerably higher than the United States, which caps its incentive at 10%, with a maximum of $500k.
Accelerated path to clinical trials in Australia
You can expect to lodge Phase 1 clinical trial applications in 8 weeks on average, compared to the 9-12 months in the US.
Consequently, through the iNGENū Australian Advantage, it is possible to access clinical data and critical Go/No Go decisions for a product in a faster timeframe than any other country.
Rapid IRB / HREC Approval
Our clients benefit from a rapid turnaround of 3 – 5 weeks for Institutional Review Board/Human Research Ethics Committee approval due to the favorable regulatory and clinical environment in Australia.
Extensive Professional Site Network in Australia
Boasting an extensive network of PIs, clinical sites, plus GCP-compliant and FDA-accredited sites across Australia.
Our application process is simple
- Book a Discovery Call with one of our Advisors by completing the form below
- We will put forward a proposal and strategy within 5 business days