Reducing Clinical
Trial Costs
iNGENū CRO specialises in helping biotechs conduct cost-effective clinical trials without compromising quality. Our expertise in regulatory strategies, trial design, and site selection allows us to maximize efficiency and minimize unnecessary expenses.
Key Factors Behind Significant Cost Reduction
R&D Tax Incentive (RDTI) for Australian Biotechs
- Eligible biotech companies can access up to a 43.5% Australian Government Research and Development Incentive – a cash refund paid directly into the Sponsor’s bank account.
- This powerful incentive significantly reduces the financial burden of clinical trials, allowing biotechs to reinvest in further development and innovation.
Strategic Use of Asia-Pacific Sites
- Where appropriate, leveraging sites in the Asia-Pacific region can further optimize costs by reducing the cost per patient while maintaining high data quality.
- Our extensive network across the region allows us to select the most suitable locations for your trial while ensuring smooth regulatory integration with Australian and global submissions.
Decentralised Clinical Trials (DCTs) for Cost Efficiency
- Our expertise in Decentralized Clinical Trials (DCTs) enables Australian biotechs to reduce operational costs while enhancing patient recruitment and retention.
- DCT models reduce reliance on traditional site-based visits, lowering overall costs and increasing trial accessibility.
Commitment to High Quality Clinical Data for FDA and EMA Submissions
iNGENū CRO ensures that clinical trials meet global regulatory requirements, with a strong focus on FDA compliance. Our team maintains strict adherence to 21 CFR 312.120 and 21 CFR Part 11, allowing data from our trials to be used in IND and NDA submissions.
All trials follow internationally recognized ethical and regulatory standards, including those set by the International Conference on Harmonisation (ICH) and the International Organization for Standardization (ISO). Our processes align with Good Clinical Practice (GCP) to ensure high-quality, reliable data.
The Therapeutic Goods Administration (TGA) maintains regulatory standards closely aligned with European Union guidelines, simplifying global regulatory acceptance. iNGENū CRO applies these frameworks to generate clinical data that meets the requirements of the FDA, EMA, and MHRA.
All clinical documentation – including Protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), and Pharmacovigilance reports – is structured for FDA submission and written in US English to ensure seamless integration with global regulatory pathways.
By maintaining rigorous compliance standards, iNGENū CRO enables biotechs to generate globally accepted clinical data while keeping trials cost-effective.