Cost efficiency

Reducing Clinical Trial Costs

iNGENū CRO reduces clinical trial costs through cost-effective research, full FDA compliance, and data structured for FDA and EMA submissions — without compromising quality.

Key factors behind significant cost reduction

Australian R&D Tax Incentive

Eligible biotech companies can access up to a 43.5% Australian Government Research & Development Incentive — a cash refund paid directly into the sponsor’s bank account. This significantly reduces the financial burden of clinical trials, allowing biotechs to reinvest in further development and innovation.

Asia-Pacific site optimisation

Where appropriate, leveraging sites across the Asia-Pacific region further optimises costs by reducing the cost per patient while maintaining high data quality. Our extensive regional network selects the most suitable locations while ensuring smooth regulatory integration with Australian and global submissions.

Decentralised clinical trials

Our expertise in decentralised clinical trials (DCTs) enables 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.

High-quality clinical data for FDA and EMA submissions

iNGENū CRO ensures 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 recognised ethical and regulatory standards, including those set by the International Council for 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 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.

Frequently asked questions

Reducing clinical trial costs — FAQs

How much can iNGENū reduce clinical trial costs?

iNGENū delivers studies at 80–90% below US CRO pricing and 30–60% below other Australian CROs, through fixed-milestone pricing, Asia-Pacific site optimisation, decentralised trial models, and the Australian R&D Tax Incentive.

What is the Australian R&D Tax Incentive?

Eligible companies can claim a refundable tax offset of up to 43.5% on qualifying R&D expenditure conducted in Australia — a cash refund paid to the sponsor, significantly lowering the effective cost of a trial. Over 99% of iNGENū clients qualify.

Does cutting cost compromise data quality or FDA acceptance?

No. All trials adhere to 21 CFR 312.120 and 21 CFR Part 11 under ICH-GCP, with documentation written in US English and structured for FDA, EMA and MHRA submissions.

How does fixed-milestone pricing save money?

Deliverables are scoped, priced and agreed before work begins, so you pay for outcomes rather than hours — no change-order inflation and no incentive to extend timelines.

Ready to discuss your clinical trial?

Talk to our team about how iNGENū CRO can accelerate your research.

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