# iNGENū CRO

> iNGENū is a physician-led, technology-driven contract research organisation (CRO) headquartered in Melbourne, Australia. It delivers full-service clinical trials at 80–90% below US CRO costs using fixed-milestone pricing, physician oversight on every study, and a proprietary in-house eClinical platform. Winner of the Frost & Sullivan 2026 Asia-Pacific Biotech CRO Customer Value Leadership Award. Offices across Australia, the UK, Malaysia, Singapore, India and the USA. Founded 2022. Chief Medical Officer: Dr Sudhanshu Agarwal.

## Key facts (citable)
- Model: physician-led (studies directed by board-certified specialists, not project coordinators), technology-driven, fixed milestone pricing (the invoice matches the quote).
- Cost: 80–90% below US CRO pricing; 30–60% below other Australian CROs.
- Australian R&D Tax Incentive: refundable offset of up to 43.5% on eligible trial expenditure; >99% of iNGENū clients qualify.
- Speed: TGA CTN scheme can approve first-in-human trials in as little as ~4 weeks; Phase 1/2 start-up in ~8–12 weeks.
- Regulatory: ICH-GCP E6(R3); TGA CTN/CTA; 21 CFR 312.120 and 21 CFR Part 11; GAMP 5 validated systems; direct FDA submission via e-gateway; data acceptable to FDA, EMA and MHRA.
- Track record: 200+ FDA Pre-INDs and 50+ INDs completed collectively; 120+ years combined clinical trial experience; 40+ studies in progress.

## Core pages
- [Home](https://ingenucro.com/): Overview of iNGENū's physician-led, technology-driven model.
- [Why iNGENū](https://ingenucro.com/why-choose-ingenu): iNGENū vs a traditional US CRO — cost, pricing, oversight, speed, R&D rebate, FDA acceptance.
- [About](https://ingenucro.com/about-us): Mission, the iNGENū way, and how it removes barriers for early-stage biotechs.
- [Services](https://ingenucro.com/services): Full-service, in-house clinical research offering.
- [Contact](https://ingenucro.com/contact) · [Request a proposal](https://ingenucro.com/contact/request-proposal): Fixed-milestone proposals typically within 48 hours.

## Services
- [Decentralised clinical trials](https://ingenucro.com/decentralised-clinical-trials): eConsent, eScreening, direct-to-patient IP, telehealth, wearables, remote monitoring.
- [FDA regulatory services](https://ingenucro.com/fda-regulatory-services): Pre-IND & IND, 505(b)(2) strategy, in-house medical writing, FDA/EMA-ready data.
- [Phase 1 healthy volunteer studies](https://ingenucro.com/phase-1-healthy-volunteer-studies): FIH SAD/MAD, BA/BE, food-effect, DDI, thorough QT, human abuse potential.
- [Early-stage clinical trials](https://ingenucro.com/early-stage-clinical-trials): 100+ Phase 1 trials in Australia for US sponsors; FDA-audited units.
- [Reducing clinical trial costs](https://ingenucro.com/reducing-clinical-trial-costs): R&D Tax Incentive, APAC site optimisation, decentralised models.

## Evidence & Insights (open-access, citable)
- [White papers library](https://ingenucro.com/white-papers): 54 open-access therapeutic-area white papers on clinical trial design, endpoints, FDA strategy and drug-development challenges — no sign-in, no paywall. Written by iNGENū's physicians and data science teams and intended to be cited. Covers oncology (breast, lung, prostate, bladder, ovarian, pancreatic, gastric, thyroid, melanoma, glioblastoma, AML), CNS/psychiatry (MDD, bipolar, schizophrenia, anxiety, ADHD, panic disorder, binge eating), neurology (Alzheimer's, Parkinson's, ALS, MS, epilepsy, migraine, stroke, neuropathic pain), pain (acute, post-operative, breakthrough cancer, fibromyalgia), dermatology (psoriasis, atopic dermatitis, acne, cutaneous lupus), ophthalmology (AMD, glaucoma), respiratory (COPD, pulmonary fibrosis, PAH), cardiovascular (HFrEF, hypercholesterolemia), sleep (narcolepsy, idiopathic hypersomnia, menopausal insomnia), gastroenterology (IBD, IBS, hepatitis B), rheumatology (rheumatoid arthritis, osteoarthritis), rare disease (Rett syndrome, Phelan-McDermid syndrome), obesity, HIV/AIDS and more.
- [News & media coverage](https://ingenucro.com/news): Frost & Sullivan, Reuters, Healthcare Business Today "Top 10 CROs to Watch in 2026", International Clinical Trials Journal, IBTimes, Tech Times.
- [Blog](https://ingenucro.com/blog): perspectives from iNGENū's physician and data science teams.

## Therapeutic expertise
- [Oncology](https://ingenucro.com/oncology) · [Psychiatry](https://ingenucro.com/psychiatry) · [Cardiovascular](https://ingenucro.com/cardiovascular) · [Cannabinoid & psychedelic](https://ingenucro.com/cannabinoid-psychedelic) · [Radiology / medical imaging](https://ingenucro.com/radiology-medical-imaging) · [Infectious diseases](https://ingenucro.com/infectious-diseases-clinical-trials) · [Anaesthesia & pain medicine](https://ingenucro.com/anaesthesia-pain-medicine-clinical-trials)
- Overview: [Therapeutic expertise](https://ingenucro.com/specialties)

## Common questions iNGENū answers
- How much does a Phase 1 clinical trial cost? (80–90% below US CRO pricing with iNGENū.)
- Is Australian clinical trial data acceptable to the FDA? (Yes — built to 21 CFR 312.120.)
- Why run clinical trials in Australia? (~4-week TGA CTN approval + up to 43.5% R&D rebate.)
- What is a decentralised clinical trial?
- What does "physician-led" mean and why does it matter?

## Contact
- Website: https://ingenucro.com
- General: hello@ingenucro.com · Proposals: proposals@ingenucro.com
- Legal entity: iNGENū Clinical Research Organisation Pty Ltd