Therapeutic Expertise

Oncology

Our experienced oncology team specialises in complex cancer trials, including advanced imaging techniques, biomarkers, and innovative therapies. We understand the complexities of oncology trials and the challenges associated with recruiting patients.

Solid tumoursHaematologic malignanciesRare cancersBreast cancer & subtypes

We are adept at managing the regulatory complexities associated with oncology trials, including those involving cutting-edge modalities like gene therapies and CAR-T therapies — combining disciplined, cost-efficient execution with the highest quality, and pairing local trials with global approvals through direct FDA regulatory expertise.

Addressing common pain points in oncology clinical trials

Advanced imaging techniques for tumour assessment

Accurate tumour assessment using advanced imaging is crucial but can pose challenges in terms of standardisation, interpretation, and technological requirements.

Oncology solution — Expertise in advanced imaging interpretation

Our team ensures standardised, reliable image acquisition and interpretation across sites.

Biomarkers for patient selection

The use of biomarkers to select suitable patients can be complex, given the vast number of potential markers and the need to validate them for accuracy and predictability.

Oncology solution — Biomarker-driven patient stratification

Leveraging advanced laboratory partnerships, we emphasise the identification and validation of robust biomarkers, ensuring the right patients receive the right treatments.

Integration of novel endpoints

Progression-free survival (PFS) and overall survival (OS) are critical outcomes but can be tricky to define, measure, and interpret compared to traditional endpoints.

Oncology solution — Adoption of advanced endpoints

Using advanced analytical tools, we ensure accurate measurement, clear definition, and insightful interpretation of these outcomes.

Complex trial designs

Oncology trials frequently involve intricate designs with a focus on specific genetic mutations, combination therapies, or patient subtypes.

Oncology solution — Specialised oncology trial design

We collaborate closely with sponsors to ensure study designs that are scientifically robust and tailored to the unique challenges of cancer research.

Regulatory and compliance issues

Due to the novel nature of many oncology treatments, there's heightened scrutiny from regulatory bodies, which makes compliance paramount.

Oncology solution — Focused regulatory compliance for oncology

Our regulatory experts stay updated on the latest oncology-specific guidelines, anticipating challenges and addressing them early.

Resources

Oncology clinical trial resources

Understanding Ovarian Cancer Clinical Trials

Epidemiology, clinical implications, and strategies for clinical trial success.

Acute Myeloid Leukemia Clinical Trials

Clinical trial strategies for the most common acute leukemia in adults.

Strategies for Breast Cancer Clinical Trial Success

Pivotal endpoints in breast cancer trials and strategies for success.

Understanding Bladder Cancer Clinical Trials

The tenth most common cancer worldwide and a significant global health challenge.

Prostate Cancer Clinical Trials

Enhancing prevention, detection, and treatment strategies.

Key Strategies for Success in Lung Cancer Clinical Trials

Improving treatments for a leading cause of cancer death worldwide.

Evidence & insights

Oncology white papers

Open-access reports from our physicians and data science teams — free, no sign-in.

Frequently asked questions

Oncology clinical trials — FAQs

Can iNGENū run oncology trials with data acceptable to the FDA?

Yes. Our oncology trials are built to ICH-GCP and 21 CFR 312.120, with direct FDA submission via the e-gateway, so data generated in Australia and the Asia-Pacific is accepted by the FDA, EMA and MHRA.

What oncology modalities and endpoints does iNGENū support?

We support solid tumours, haematologic malignancies, rare cancers and advanced modalities including gene and CAR-T therapies, with biomarker-driven patient selection and endpoints such as progression-free survival (PFS) and overall survival (OS).

How does iNGENū reduce the cost of an oncology trial?

Through Australia’s refundable R&D Tax Incentive (up to 43.5%), fixed-milestone pricing, and Asia-Pacific site optimisation — typically 80–90% below US CRO pricing without compromising quality.

The iNGENū CRO difference

Australian expertise, direct FDA submission

We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.

iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.

“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”

Giles MossChief Executive Officer

Ready to discuss your Oncology clinical trial?

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

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