In the world of drug development, the timing and design of clinical trials can be crucial in getting a new drug to market ahead of competition. iNGENū is a leader in helping small and emerging drugmakers design and implement trial plans that maximize both efficiency and cost savings.
Thanks to the favorable research environment in Australia and iNGENū’s scientifically-based research strategies, U.S. firms can see an overall cost savings of 70% compared to working with American research partners.
iNGENū has developed a streamlined, efficient process for all aspects of clinical trial administration. From decentralized recruitment to FDA-ready reporting systems to tax rebates for conducting trials in Australia, iNGENū can move your research forward.
Research and Development Tax Incentive (RDTI)
The Australian government offers substantial tax incentives for companies conducting crucial research and development work within Australia. Foreign entities can benefit from these tax incentives by partnering with an eligible Australian R&D entity. Rebates can be as high as 43.5% of research costs payable directly to your company.
iNGENū can conduct up to 100% of the clinical elements of your research in Australia, to maximize your tax rebate eligibility. All elements of project management, clinical data management, biostatistics, regulatory oversight, and clinical trial monitoring can be counted toward the rebate amount. We will work with you to structure a clinical trial plan that nets the highest possible Australian RDTI payment.
Streamlined Research Environment
Conducting research in Australia offers additional opportunities for cost savings. The clinical research framework in Australia is more cost-efficient than comparable systems in the U.S., Canada, or Europe without sacrificing compliance in those markets.
The regulatory pathway that guides research practices in Australia permits study sponsors to cite prior research when designing their trials. This can reduce the number of preclinical studies needed before beginning in-human trials. The cost savings can be substantial, and research can advance more quickly, resulting in an expedited pathway to approval.
Best Practices for Cost Management
iNGENū provides end-to-end management of research projects. Our internal team oversees regulatory, preclinical, and clinical work, with consistent coordination between staff on all phases of your project. This comprehensive approach maximizes efficiency and cost-effectiveness.
iNGENū also leverages technology solutions for decentralizing clinical trials. We start with advanced digital recruitment strategies using data analytics and targeted outreach. Our remote e-screening and e-consent processes don’t require participants to travel to a research site, which accelerates enrollment across a diverse participant base and decreases recruitment and enrollment costs.
During the trial itself, we can utilize various combinations of remote technologies for real-time data collection, including Electronic Patient-Reported Outcomes (ePRO), Electronic Clinical Outcome Assessments (eCOA), and Electronic Clinician-Reported Outcomes (eClinRO). Remote technology decreases barriers to patient participants and improves participant retention for more robust data without additional recruiting and enrollment.
All clinical trial data is securely collected and reviewed by independent experts to maintain the integrity and reliability of trial results. We value delivering high-quality clinical research at a fraction of the cost and helping you to realize the full measure of RDTI.
International Regulatory Expertise
There is no need to bring in private consultants to ensure that research conducted in Australia is compliant with U.S. regulations. The team at iNGENū has considerable expertise and experience with the requirements for U.S. FDA Pre-Investigational New Drug (Pre-IND) and Investigational New Drug (IND) applications. You can be assured that your trial results will be transferable to U.S. authorities for further approval.
iNGENū’s core mission is to facilitate high-quality clinical research by removing unnecessary barriers. If you are interested in learning more about how iNGENū can accelerate your research and maximize your budget, we invite you to contact us today.