About iNGENū CRO
iNGENū is the Australian CRO championing innovative biotech firms for global success.. We are physician-led, providing access to the full spectrum of clinical and non-clinical research services.
Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnecessary barriers.
The iNGENū way
Drastically lowering clinic entrance fees
- Utilising the Australian Government's 43.5% R&D Incentive for clinical, non-clinical, bioanalytical, CMC and trial IP manufacturing (>99% of our clients qualify)
- Minimising the number of preclinical studies needed to perform the first-in-human clinical trial
- Introducing Venture Capitalists and funding groups who are targeting biotechs performing early stage clinical trials (>50% of our clients win additional funding from VC groups that we introduce)
- Unlocking access to other Australian Federal and State incentives for performing research
Reducing the time to start clinical studies
- Australian clinical research offers the unique opportunity of capturing 21 CFR 312.120, FDA-compliant data without an IND – dramatically shortening the time to conducting early-stage clinical studies
- Leveraging bibliographic non-clinical safety data to minimise the extra number of non-clinical studies needed to commence in-human clinical studies
- Start-up times for Phase 1 or 2 trials in Australia is as short as 8-12 weeks
The Advantage
- Deep-level partnering with Sponsors – our relationships are for life
- Using the FDA regulatory pathway via both 505(b)2 and 505(b)1 to maximise vouchers and incentives (Fastrack, Accelerated, PRV, Breakthrough, ODD). Our team have completed >200 FDA Pre-INDs and >50 INDs collectively
- Introducing access to novel funding solutions for early-stage biotechs seeking top-up funding for trials (VCs, Biotech-focused Funds, Government Grants)
- Globalising research to maximise R&D incentives across:
- Australia (R&D Tax Incentive)
- Asia-Pacific Region (R&D Tax Deduction)
- UK (RDEC and SME)
- NZ (Callaghan Innovation Grant)
- USA (to meet FDA diversity targets for later-stage trials)
Our Typical Client
An early-stage biotech company who is looking for:
- Cost-effective trial expansion while maintaining high standards of quality and compliance
- Expert guidance on conducting clinical trials in Australia and the Asia-Pacific region
- A streamlined path to global regulatory approvals, including the U.S. FDA
- All data being 21 CFR 312.120 compliant for US FDA submission
- Clinical trial start-up time in as little as 8-10 weeks