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About

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.

iNGENū CRO is a physician-led Australian contract research organisation (CRO) running FDA-ready Phase 1–4 clinical trials for biotech and pharmaceutical sponsors worldwide — at 80–90% below US cost, with ~4-week ethics approval and up to a 43.5% R&D rebate.

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

  • 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 targeting biotechs performing early-stage clinical trials (>50% of our clients win additional VC funding we introduce).
  • Unlocking access to other Australian federal and state incentives for performing research.
  • Capturing 21 CFR 312.120, FDA-compliant data without an IND — dramatically shortening the time to early-stage studies.
  • Leveraging bibliographic non-clinical safety data to minimise the number of extra non-clinical studies needed.
  • Start-up times for Phase 1 or 2 trials in Australia as short as 8–12 weeks.
  • 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 (Fast Track, Accelerated, PRV, Breakthrough, ODD). Our team has completed >200 FDA Pre-INDs and >50 INDs collectively.
  • Globalising research to maximise R&D incentives across Australia, Asia-Pacific, the UK, New Zealand, and the USA.

Who we work with

Our typical client

The sponsors we serve share a common profile: ambitious biotechs that need FDA-grade data, faster and more affordably than the traditional model allows.

  1. 1An emerging biotechnology company — typically headquartered in the United States, United Kingdom, China or Switzerland — advancing a novel therapeutic toward the clinic.
  2. 2Committed to generating high-quality clinical data that satisfies the regulatory requirements of the US FDA.
  3. 3Not yet in a position to open an IND, often because preclinical data is incomplete or there are outstanding CMC gaps to resolve.
  4. 4Focused on minimising the cost of a Phase 1 or Phase 2 trial while maximising eligibility for government R&D tax credits.
  5. 5Seeking to reduce the cost per patient in Phase 2 by conducting studies at high-quality, lower-cost sites across the Asia-Pacific region.
  6. 6Determined to accelerate study start-up — securing ethics and regulatory approvals in a matter of weeks rather than months.

Ready to discuss your trial?

Talk to our team about how iNGENū CRO can accelerate your research.

Request a proposal