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