Why Choose iNGENū CRO?
Accelerate your drug development with our 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, offering a streamlined path for sponsors to achieve global approval. Our seamless integration allows trial data from Australia to be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
Partnering with iNGENū means benefiting from our deep understanding of Australian clinical trials, paired with our proven ability to navigate U.S. regulatory requirements. Whether you're an Australian company looking to expand your reach or a global sponsor seeking operational efficiency, we provide the ideal solution.
Our direct FDA submission capability ensures that your data flows effortlessly from local trials to U.S. regulatory approval, positioning you for success on the global stage while retaining the operational benefits of working within Australia.
Questions you should ask your CRO
- Can my trial data be submitted directly to the FDA without third-party intermediaries?
- What experience does your team have in navigating both Australian and U.S. regulatory requirements?

Disciplined, Cost-Efficient Execution
iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes. Our trials are designed with efficiency in mind, eliminating unnecessary costs while maintaining the highest scientific and regulatory standards.
By streamlining processes and optimising trial execution, we help sponsors maximise their budgets without compromising the integrity or quality of their studies.
Thoughtful trial management leads to better results at a lower cost. We focus on operational precision, reducing inefficiencies, and ensuring that every stage of the study is designed for streamlined execution. This means optimised spending, faster timelines, and high-quality data – without excess.
Questions you should ask your CRO
- How do you optimise trial execution to maximise cost efficiency without sacrificing quality?
- What specific measures do you take to minimise unnecessary trial costs?

Australian-Headquartered, Asia-Pacific Reach
iNGENū provides Australian sponsors with comprehensive trial capabilities across the Asia-Pacific region, offering a seamless combination of cost-efficiency and high-quality clinical trials.
All project management, clinical data, and statistical analysis are managed in Australia, ensuring that every trial is supported by expert teams within the same time zone. This streamlined approach allows for consistent communication, alignment, and oversight throughout the trial process, offering sponsors the confidence of Australian quality control combined with the strategic advantages of APAC sites.
Our model ensures that sponsors can access a broader range of trial sites, enhancing the speed and scalability of their research while optimising costs.
Questions you should ask your CRO
- Do you have the capability to run multi-site clinical trials across the Asia-Pacific region?
- How do you ensure seamless project management and regulatory compliance across multiple countries?

Expertise from the Start
At iNGENū CRO, you engage directly with experienced specialists from the outset. Our team, comprised of highly qualified doctors and PhD scientists, provides immediate, precise answers to your complex inquiries, ensuring efficiency and high-level communication.
You will always interact with experts who understand and address your unique challenges, enabling seamless transitions from initial discussions to actionable plans, accelerating your project's progress.
Our clinical team has over 120 years of combined clinical trial experience. With our proven track record of guiding sponsors through drug development, iNGENū CRO ensures smooth execution at each phase.
Questions you should ask your CRO
- How soon can I speak directly with a specialist or senior-level expert?
- What is the combined clinical trial experience of your team?

Highly Customised Drug Development Plans
iNGENū CRO stands out for our ability to create highly customised drug development plans. Our experienced team leverages their extensive background in standard and non-standard pharmaceutical practices to develop innovative solutions tailored to your specific drug.
Each drug has unique, patentable aspects that require a customised approach. Our expertise allows us to provide creative and scientifically backed strategies, ensuring a robust development plan. We offer a level of customisation that maximises your drug's potential for success, providing you with a clear and effective path forward.
Questions you should ask your CRO
- How do you customise drug development plans to fit unique, patentable aspects of my drug?
- Can you provide examples of innovative solutions you have implemented for other sponsors?

Full-Service CRO
We provide a full range of services from preclinical research through Phase 1, 2, and 3 clinical trials. Unlike other CROs that may outsource certain stages or recommend third-party vendors, iNGENū CRO handles everything in-house.
We have a full FDA regulatory team with an e-service gateway for IND submissions to the FDA.
This integrated approach ensures seamless communication and coordination across all phases of your project. Our regulatory, preclinical, and clinical teams work in tandem to optimise the management of your project, as well as maximise efficiency and cost-effectiveness.
Questions you should ask your CRO
- Do you do your own Pre-IND and IND submissions to the FDA in-house?
- Do you outsource any stages of the clinical trial process?
- Can you handle preclinical, phase 1, 2, and 3 trials in-house?
Ready to take the next step?
At iNGENū CRO, we pride ourselves on being leaders in clinical research and drug development. Our core mission is to create access to high quality clinical research globally by removing financial and other unnecessary barriers.
If our approach and dedication align with your goals, we invite you to contact us.

"We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have used iNGENū for: Medical writing, project management, clinical data management and full end-to-end, clinical trial execution and monitoring.
We have been very happy with all aspects of the management of the clinical trial and have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads for our company during this clinical trial."
Giles Moss
Chief Executive Officer