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 in early-stage clinical trials with a streamlined path for sponsors to achieve global approval. Our scientists integration allows real-time data from Australia to be submitted directly to the FDA via our F-Gateway, eliminating the need for third-party intermediaries.
Questions you should ask your CRO
- What experienced data scientists lead trials in Australia? Why is their work U.S. FDA or UK regulatory compliant?
- How do you ensure seamless data management and regulatory compliance across all third-party intermediaries?
Disciplined, Cost-Efficient Execution
iNGENū CRO follows a highly strategic and disciplined approach to clinical research, carefully balancing robust study design with generating meaningful outcomes. Our trials are rigorously designed to provide high-quality data, while proactively minimizing unnecessary costs while maintaining the highest standards and compliance.
Questions you should ask your CRO
- What’s your R&D Tax assistance process for maximizing cost savings?
- How do you balance cost and clinical trial quality?
- What specific measures do you take to reduce unnecessary trial costs?
Australian-Headquartered, Asia-Pacific Reach
iNGENū provides Australian sponsors with comprehensive trial capabilities across the Asia-Pacific region, offering a seamless experience from initial study set-up to high-quality clinical trials.
Questions you should ask your CRO
- How do you ensure seamless study management across diverse sites in Australia and Asia-Pacific?
- What specific expertise do you have in navigating both Australian and U.S. regulatory requirements?
- How are clinical data maintained to meet both Australian/APAC and U.S./European regulatory standards?
Expertise from the Start
At iNGENū CRO, you engage directly with experienced project leaders from day one. Our Chief Executive Officer, Medical Director, and PhD scientists, provides immediate, precise guidance throughout your trial. This ensures efficient and high-level communication.
Questions you should ask your CRO
- How soon can I speak directly with a specialist or senior-level expert?
- What is the collective clinical experience of your front-line leadership?
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 processes to develop realistic solutions tailored to your specific drug development needs.
Questions you should ask your CRO
- How do you develop robust, yet flexible, development plans for complex, first-in-human trials?
- Can you give examples of innovative solutions you have recommended for when standard paths were not suitable?
- How do you balance regulatory guidelines with practical requirements for when sponsor?
- Do you develop plans and strategies only, or are you set up for seamless project plan to actual implementation?
Full-Service CRO
We provide a full range of services from preclinical research through to Phase 1, 2 and 3 clinical trials. Unlike other CROs that may outsource elements or recommend third-party vendors, iNGENū CRO handles everything in-house.
Questions you should ask your CRO
- Does your CRO offer Pre-IND and IND submission to the FDA or do you outsource these services?
- Do you have full FDA regulatory team with an extended advisory pathway for regulatory submissions for the FDA?
- Can you handle preclinical, phase 1, 2, and 3 trials in-house?
Ready to take the next step?
At iNGENū CRO, we pride ourselves as living leaders in clinical research and drug development. Our core mission is to ensure access to high quality clinical research globally for biotechs by removing financial and other unnecessary barriers.
If our approach and specialisation align with your goals, we invite you to contact us.
“We have been using iNGENū for +8 trials. It runs like human heart at our investigational drug. We know the iNGENū Medical, writing, project management, Clinical Data Management and Bio statistics team, because we started the day. We trust the operational excellence and how the creative solutions to operate and reduce unnecessary interfaces for our proprietary IP data. This clinical trial is absolutely key.”