Physician-led · Technology-driven · 5 Global offices

Elite clinical research.
Intelligently delivered.

iNGENū is a full-service, physician-led CRO delivering the scientific rigour and regulatory precision of a top-tier US clinical research organisation — underpinned by proprietary in-house technology and priced for the way clinical trials should work.

Request a proposal Why iNGENū

100%

Physician-owned

Global offices

40+

Studies in progress

80–90%

Below US CRO costs

Industry recognition

Frost & Sullivan 2026 Asia-Pacific Biotech CRO Customer Value Leadership Award

Recognised for reimagining the CRO model through physician-led engagement, proprietary technology, and an integrated clinical architecture that transforms trial execution across the Asia-Pacific region.

The iNGENū difference

Full-service capability. Purpose-built technology. Physician-grade oversight.

iNGENū was engineered from inception as a fully integrated, technology-native clinical research organisation — with real-time reporting, risk-based quality management, continuous self-audited quality systems, and a fully integrated eClinical suite, with physician oversight at every clinical decision point.

Specialist-led

Every study directed by a qualified, board-certified medical specialist — not managed by project coordinators reading from a playbook.

Technology-driven

Proprietary in-house technology platform with real-time reporting, risk-based quality management, and a fully integrated eClinical suite — with physician oversight at every step.

Fixed pricing

Milestone-based billing. You pay for outcomes delivered, not hours consumed. The invoice matches the quote.

Therapeutic expertise

Deep experience where it matters most.

Unparalleled expertise in novel, challenging clinical products and less common routes of administration — the studies other CROs hesitate to take on.

OncologyNeuroscienceOphthalmologyDermatology & cosmeticPerioperativeRare & orphan diseasesCardiovascular Cannabinoid & psychedelicCell & gene therapyNovel formulationsComplex routes of administrationAnaesthesia & pain medicine Early-stage clinical trials

Evidence & insights

54 open-access white papers. No paywall.

Our physicians and data-science teams publish open-access therapeutic-area reports on trial design, endpoints and FDA strategy — written to be read, and cited, by the research community.

Browse white papers News & media

What sponsors say

Trusted by biotech and pharma sponsors worldwide.

“We have been using iNGENū for a Phase 1, first-in-human clinical trial of our breakthrough drug. We have been nothing but impressed by their R&D and GCP knowledge, clinical capability, project management, clinical data management, and also their very friendly way of managing and explaining the data.”

Giles MossChief Executive Officer, Avata Bio

“What stood out immediately was the agility. Decisions that would take weeks at a larger CRO were resolved in days, without any compromise on rigour or regulatory compliance. The pricing was unmatched — significantly below every other credible option we evaluated.”

Dr Mohit GoyalChief Medical Officer, Grey Matter Pharma

Frequently asked questions

Questions biotech sponsors ask us.

What is iNGENū CRO and how is it different from traditional CROs?

iNGENū is a physician-led, technology-driven contract research organisation headquartered in Melbourne, Australia. Unlike traditional CROs that bill by the hour, iNGENū uses fixed milestone pricing — you pay for deliverables, not timesheets. Every study is directed by a clinical research physician, and our proprietary in-house technology platform handles data reconciliation, monitoring reports, and regulatory assembly, reducing costs by 80-90% compared to US CROs.

How much does a clinical trial cost with iNGENū?

Costs depend on phase, therapeutic area, number of sites, and services required. As a guide, iNGENū delivers studies at 80-90% below US CRO pricing and 30-60% below other Australian CROs. Request a formal fixed-milestone proposal — typically delivered within 48 hours.

Why run clinical trials in Australia instead of the US, EU, UK, or Asia?

Australia offers one of the fastest regulatory pathways in the world — the TGA CTN scheme can approve trials in as little as four weeks, compared to months in the USA, EU, UK, and Asia. The R&D Tax Incentive provides up to 43.5% tax offset on eligible trial expenditure. And Australia has ICH-GCP-compliant infrastructure, experienced investigators, and ethnically diverse patient populations at a fraction of US costs.

What does 'physician-led' mean at iNGENū?

Every iNGENū study is directed — not just reviewed — by a qualified, board-certified medical specialist. From protocol design through to the clinical study report, a specialist physician makes the clinical decisions. This is fundamentally different from traditional CROs where project coordinators manage studies and physicians are consulted intermittently as reviewers.

What is fixed milestone pricing and how does it save money?

Fixed milestone pricing means every deliverable is scoped, priced, and agreed before work begins. You pay when milestones are met, not when timesheets are submitted. There are no contingency surcharges, no change order inflation, and no incentive for iNGENū to extend your timeline. If our technology completes a monitoring review in 2 hours instead of 20, you don't pay for 20.

What therapeutic areas does iNGENū specialise in?

iNGENū has deep expertise across oncology, neuroscience, ophthalmology, dermatology, rare diseases, cardiovascular, cell and gene therapy, novel formulations, and complex routes of administration — including intrathecal, intraocular, inhaled, and transdermal delivery. We specialise in the studies other CROs hesitate to take on.

Is iNGENū compliant with international regulatory standards?

Yes. All iNGENū studies are conducted under ICH-GCP E6(R3). We operate within TGA CTN/CTA frameworks, comply with 21 CFR Part 11 for electronic records, and maintain GAMP 5 validated systems. Our technology platform is developed under a validated software lifecycle, and all outputs receive physician sign-off.

What is the Australian R&D Tax Incentive for clinical trials?

The Australian R&D Tax Incentive provides eligible companies with a tax offset of up to 43.5% on qualifying clinical trial expenditure conducted in Australia. This can significantly reduce the effective cost of your trial. iNGENū’s team can help you understand eligibility and maximise the benefit.

See what your study would cost.

Submit your study requirements and our team will be in contact within 48 hours.

Get a proposal

Elite clinical research.Intelligently delivered.