Melbourne, VIC
Phase 1 CRO in Melbourne
iNGENū is a physician-led Phase 1 CRO headquartered in Melbourne, Australia — first-in-human and healthy-volunteer studies, ~4-week ethics, no IND, and the 43.5% R&D rebate, with FDA-ready data.
A physician-led Phase 1 CRO, based in Melbourne
iNGENū is headquartered at 22/456 St Kilda Road, Melbourne, VIC — running Phase 1 and first-in-human studies for biotech and pharma sponsors worldwide. Sponsors choose Melbourne for the combination of fast HREC ethics timelines (~4 weeks), no IND requirement before dosing, early-phase costs 80–90% below US CROs, and the 43.5% refundable R&D tax rebate — all producing data accepted by the FDA and EMA.
Frequently asked questions
Phase 1 CRO in Melbourne — FAQs
Is there a Phase 1 CRO in Melbourne?
Yes. iNGENū is a physician-led, full-service Phase 1 CRO headquartered in Melbourne, VIC, running first-in-human and healthy-volunteer studies with ~4-week ethics timelines, no IND requirement, and the 43.5% R&D rebate.
What Phase 1 services does iNGENū offer in Melbourne?
iNGENū delivers Phase 1 end-to-end — protocol design, ethics submission, healthy-volunteer recruitment, dose escalation, safety monitoring, data management and biostatistics — under in-house physician oversight, with data structured for FDA and EMA.
How fast can a Phase 1 trial start in Melbourne?
With no IND and HREC ethics approval in roughly 4 weeks, Phase 1 start-up in Melbourne is among the fastest globally. iNGENū’s in-house regulatory and operations teams compress start-up further.
Is Melbourne Phase 1 data accepted by the FDA?
Yes. Studies run to ICH-GCP and 21 CFR Part 11, and the data is routinely accepted in FDA IND/NDA and EMA submissions.
Run your Phase 1 in Melbourne
Talk to our Melbourne-based team about your first-in-human or Phase 1 study.
Request a proposal