Services
Our services
iNGENū is a full-service CRO — every stage from preclinical through Phase 1–4 handled in-house, with physician oversight and proprietary technology throughout.
Decentralised clinical trials
Patient-centric DCTs — eConsent, eScreening, direct-to-patient IP delivery, telehealth, wearables and remote monitoring.
Learn more →FDA regulatory services
Pre-IND & IND applications, 505(b)(2) strategy, and in-house medical writing producing FDA- and EMA-ready data.
Learn more →Phase 1 healthy volunteer studies
Physician-led first-in-human SAD/MAD, bioavailability, food-effect and DDI trials, FDA-ready by design.
Learn more →Early-stage clinical trials
100+ Phase 1 trials in Australia for US sponsors, with FDA-audited units and PK/PD expertise.
Learn more →Reducing clinical trial costs
Up to 43.5% R&D Tax Incentive, Asia-Pacific site optimisation, and DCT models — without compromising quality.
Learn more →Delivered in-house
Ready to discuss your clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
Request a proposal