About iNGENū CRO

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative US and global biotech firms. We are physician-led, providing access to the full spectrum of clinical and nonclinical 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

  • Utilizing the Australian Government's 43.5% R&D Incentive for clinical, nonclinical, bioanalytical, CMC and trial IP manufacturing (>99% of our clients qualify)
  • Minimizing 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 nonclinical safety data to minimize the extra number of nonclinical 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 maximize 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)
  • Globalizing research to maximize R&D incentives across:
    - Australia (R&D Tax Incentive)
    - 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: 

  • >70% cost reduction on FDA-compliant clinical and nonclinical trials
  • All data being 21 CFR 312.120 compliant for US FDA submission
  • Clinical trial start-up time in as little as 8-10 weeks
  • Commence first-in-human clinical trials prior to opening an IND
  • Perform first and second-species nonclinical studies at a fraction of the cost of the US

Meet the Team

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Ready to discuss your trial?