Why iNGENū
Why choose iNGENū CRO?
Accelerate your drug development with direct FDA submission, cost-efficient execution, and expert-led, full-service support.
Local trials, global approvals
We uniquely combine Australian expertise with direct FDA submission capabilities. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating third-party intermediaries. Whether you are an Australian company expanding your reach or a global sponsor seeking operational efficiency, your data flows effortlessly from local trials to US regulatory approval.
Disciplined, cost-efficient execution
We take a strategic, disciplined approach so every dollar is directed toward meaningful outcomes. By streamlining processes and optimising execution, we help sponsors maximise budgets without compromising integrity or quality — optimised spending, faster timelines, and high-quality data without excess.
Australian-headquartered, Asia-Pacific reach
All project management, clinical data, and statistical analysis are managed in Australia, ensuring every trial is supported by expert teams in the same time zone. Sponsors gain the confidence of Australian quality control combined with the strategic advantages of APAC sites — broader site access, greater speed and scalability, and optimised costs.
Expertise from the start
You engage directly with experienced specialists from the outset — highly qualified doctors and PhD scientists who provide immediate, precise answers to complex inquiries. Our clinical team has over 120 years of combined clinical trial experience.
Highly customised drug development plans
Each drug has unique, patentable aspects that require a customised approach. Our team leverages extensive experience in standard and non-standard pharmaceutical practices to develop creative, scientifically backed strategies that maximise your drug’s potential for success.
Full-service CRO
We provide a full range of services from preclinical research through Phase 1, 2, and 3 trials — handled in-house, not outsourced. We have a full FDA regulatory team with an e-service gateway for IND submissions, ensuring seamless communication and coordination across all phases of your project.
iNGENū vs a traditional US CRO
How iNGENū compares
| Factor | iNGENū (Australia) | Traditional US CRO |
|---|---|---|
| Trial cost | 80–90% lower | Baseline (highest) |
| Pricing model | Fixed milestone — invoice matches quote | Hourly / pass-through, change-order inflation |
| Study oversight | Directed by a board-certified physician | Managed by project coordinators |
| First-in-human approval | TGA CTN — as fast as ~4 weeks | IND process — often months |
| R&D cost offset | Up to 43.5% Australian R&D Tax Incentive | None equivalent |
| FDA acceptance | 21 CFR 312.120 data, direct e-gateway submission | FDA-native |
Cost and timeline figures are indicative; request a fixed-milestone proposal for study-specific numbers.
Ready to discuss your clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
Request a proposal