Why Choose iNGENū CRO?

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 Customized Drug Development Plans

iNGENū CRO stands out for our ability to create highly customized 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 customized approach. Our expertise allows us to provide creative and scientifically backed strategies, ensuring a robust development plan. We offer a level of customization that maximizes your drug's potential for success, providing you with a clear and effective path forward.

Questions you should ask your CRO

• How do you customize 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 optimize the management of your project, as well as maximize 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?

Maximizing R&D Tax Incentives

Choosing iNGENu CRO means ensuring that you receive the maximum Research and Development Tax Incentive (RDTI) available. At your request, we can conduct 100% of our clinical work in Australia (inclusive of all project management, clinical data management, biostatistics, regulatory, trial monitoring), to ensure the highest proportion of any payments qualify for the full Australian RDTI.

Many other "Australian" CROs conduct a significant portion of their work overseas, which can reduce the fraction of work eligible for the RDTI. By partnering with iNGENū, you benefit from substantial cost savings, as all our clinical work is eligible for the Australian RDTI, providing you with more financial return on your investment.

*Subject to sponsor eligibility. Click here to view eligibility criteria and to learn more about the Australian Government's R&D Tax Incentive.

Questions you should ask your CRO

• What percentage of your clinical work is conducted in Australia?
• How do you maximize the Research and Development Tax Incentive for your clients?

Australian-Focused Global Reach

iNGENū CRO's capabilities extend worldwide. Our decentralized clinical trials model allows us to engage participants from various geographic locations, ensuring diverse and representative study populations.

Our global reach is facilitated through a network of strategic partnerships and advanced technological platforms, enabling seamless communication and coordination across borders. By choosing iNGENū CRO, you benefit from our deep local expertise combined with a global perspective, ensuring your clinical trial is conducted with quality and efficiency, no matter where it takes place.

Questions you should ask your CRO

• How do you leverage your local expertise to manage clinical trials on a global scale?
• What infrastructure do you have in place to support international clinical trials?

Full Decentralized Capabilities

The landscape of clinical research is evolving with decentralized clinical trials (DCTs). At iNGENū CRO, we are at the forefront of this transformation, offering comprehensive decentralized trial capabilities.

Decentralized clinical trials remove the need for traditional clinical sites, leveraging technology to conduct trials remotely. This approach allows patients to participate from their homes, significantly enhancing convenience and accessibility. Throughout the trial, patients receive study medications directly to their homes, and all consultations with healthcare professionals are conducted through telehealth, ensuring continuous medical oversight.

This approach reduces patient burden, significantly increases retention rates, expands access to diverse populations, accelerates timelines by minimizing logistical delays, and enhances cost efficiency by cutting site maintenance fees. Data quality and patient safety are maintained through rigorous protocols and technological solutions.

Questions you should ask your CRO

• Do you offer full decentralized clinical trial capabilities, and how do you implement them?
• What protocols and quality assurance measures are in place to ensure patient safety and data integrity in decentralized clinical trials?