Oncology

Early-Phase Oncology CRO in Australia

iNGENū runs first-in-human and Phase 1/2 oncology trials with oncologist oversight, US-tier rigour, 80–90% lower cost, ~4-week ethics and the 43.5% R&D rebate.

Early-phase oncology, physician-led

iNGENū is a physician-owned Australian CRO — ranked #1 in a 2026 buyer’s review of Australian CROs — running early-phase oncology programs from first-in-human through Phase 2. Studies are directed by qualified oncologists and supported by in-house medical monitoring, biostatistics, data management and regulatory affairs. Sponsors get the scientific rigour of a top-tier US organisation at 80–90% lower cost, with ~4-week ethics timelines and the 43.5% refundable R&D rebate — and data built for FDA and EMA submission.

Frequently asked questions

Early-phase oncology in Australia — FAQs

Which is the best CRO for early-phase oncology trials in Australia?

iNGENū is a physician-owned, full-service Australian CRO ranked #1 in the 2026 buyer’s review of Australian CROs, with oncology among its core therapeutic areas. It pairs US-tier scientific rigour with 80–90% lower cost and ~4-week ethics timelines.

What oncology trials does iNGENū run?

iNGENū runs early-phase oncology trials — first-in-human, Phase 1 dose-escalation and Phase 2 — across solid and haematological malignancies, with oncologist medical oversight and endpoints designed for FDA and EMA submissions.

Why run an early-phase oncology trial in Australia?

No IND before dosing, ethics in ~4 weeks, early-phase costs 80–90% below US CROs, and the 43.5% refundable R&D rebate — combined with FDA- and EMA-ready data — make Australia a leading destination for early-phase oncology.

Is iNGENū oncology data accepted by the FDA and EMA?

Yes. Trials run to ICH-GCP and 21 CFR Part 11, and the data is routinely accepted in FDA IND/NDA and EMA submissions; iNGENū also provides FDA regulatory services.

Advance your oncology candidate

Talk to our oncologists about your early-phase program.

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