Reducing Clinical
Trial Costs
iNGENū maintain stringent standards around compliance with the requirements of US Federal legislation for clinical trials including 21 CFR 312.120 and 21 CFR Part 11 to ensure FDA-compliant data which can form part of your IND and NDA submission.
Clinical trials with iNGENū typically cost 70% less than a comparable US CRO.
Key Factors Behind Significant Cost Reduction
- 43.5% Australian Government R&D incentive – a cash refund paid directly into the Sponsor’s bank account
- Australia already offers more cost-effective clinical research compared to the US, Canada or Europe
- Expediting the approval and study startup process, resulting in further cost-savings
- Full GMP Investigational Product manufacturing is not required for phase 1 clinical trials
- A highly efficient operating structure allows us to leverage best practice strategies and pass on savings to our clients
- Minimizing the number of preclinical studies needed to perform the first-in-human clinical trial
- Unlocking access to other Australian Federal and State incentives additional to the 43.5% R&D Incentive
Commitment to High Quality Clinical Data for FDA and EMA Submissions
Australia adheres to a well-developed ethical and regulatory framework. The standard codes of conduct are adopted from the International Conference on Harmonisation (ICH) and the International Organization for Standardization (ISO).
Australia’s scientific and clinical community also mandates the standards of Good Clinical Practice (GCP) across all trials, ensuring high-quality results.
The Therapeutic Goods Administration (TGA) also closely aligns its prevailing regulatory standards with international counterparts including the relevant European Union guidelines, allowing for easier integration and acceptance by institutions globally.
Data output quality from studies conducted in Australia can be used to support almost all major international regulatory applications, including the US FDA and European Medicines Agency (EMA), and Medicines and Healthcare products Regulatory Agency (MHRA).
At iNGENū, our Quality Assurance team are fluent in FDA guidance, and we are uniquely structured as an Australian-based CRO operating primarily to capture data intended for FDA submission.
Hence, all our clinical writing (including Protocols, IB’s CSRs, Pharmacovigilance reports) is written in US English and structured for submission to the FDA.