iNGENū CRO

A comprehensive clinical trial service supporting advanced therapy programmes such as CAR-T, gene therapies, and other ATMPs, focusing on complex logistics, safety profiles, and long-term follow-up.

iNGENū manages first-in-human and Phase 1 clinical studies end-to-end in Australia, offering fast ethics approval (~4 weeks), no IND requirement, established healthy-volunteer units, and cost advantages including a 43.5% R&D rebate across 150+ indications.

Comprehensive clinical trial services for central nervous system disorders including neurodegenerative diseases, movement disorders, epilepsy, migraine, and stroke, with physician oversight and standardized endpoint capture.

Provides sponsors with high-quality, continuous, real-time data through state-of-the-art digital tools and platforms, empowering informed decision-making throughout the trial process.

Specialised cardiovascular safety team using cutting-edge monitoring technologies focused on cardiovascular risk factors and outcomes in clinical trials.

Guidance and in-house services for sponsors through FDA Pre-IND & IND applications, producing high-quality clinical data for FDA and EMA submission, while capturing Australia's R&D Tax Incentive.

Clinical development services specializing in novel and reformulated products, including modified-release, long-acting, and combination formulations, with a focus on 505(b)(2) regulatory pathways.

Advanced digital recruitment strategies leveraging data analytics and targeted outreach to efficiently identify and engage potential trial participants, optimising recruitment timelines.

Clinical trial design with robust blinding methods, run-in periods, crossover designs, and advanced statistical methodologies to account for variability and placebo effects in respiratory trials.

Regulatory affairs support for pulmonology-specific submissions including INDs, NDAs, and device approvals to navigate complex regulatory pathways efficiently.

Technologies enabling real-time data capture and analysis of patient-reported outcomes, clinical outcome assessments, and clinician-reported outcomes in decentralised clinical trials.

A platform with standardised protocols and trained specialists to ensure consistent imaging techniques and improved data quality across clinical trial sites.

A streamlined, digital consent process compliant with all regulatory requirements, allowing patients to provide informed consent remotely with ease.

Service to ship investigational products directly to patients’ homes, reducing the need for site visits and ensuring timely access to treatments.

Clinical trial services for products delivered by challenging routes such as inhaled, intranasal, intrathecal, ophthalmic, transdermal, implantable and drug-device combinations, focusing on administration science, PK, safety, usability, and regulatory considerations.

Remote monitoring capabilities allowing continuous oversight of trial activities to ensure compliance and data accuracy while minimising on-site visits.

An electronic screening process that ensures patients can be quickly and accurately assessed for eligibility without the need for physical site visits, speeding up the recruitment process.

Patient recruitment and retention strategies leveraging extensive patient databases, collaborations with specialists, and patient advocacy groups, including flexible visit schedules and remote monitoring.

Incorporates wearables and digital tools to continuously monitor and collect vital signs data in real time, providing a comprehensive picture of patient health throughout the trial.

Ensures efficacy data is centrally routed and reviewed by independent experts to maintain integrity and reliability of trial results.

Facilitates remote consultations with trial investigators, allowing patients to receive medical guidance and support without leaving their homes.

Standardised protocols for spirometry and imaging (e.g., HRCT, PET) and advanced biomarker analysis to ensure reliable, high-quality data collection across all trial sites in respiratory medicine clinical trials.

State-of-the-art safety monitoring systems providing real-time surveillance and prompt intervention for adverse events in respiratory clinical trials.

Combines validated objective measures with patient-reported outcomes under a coherent analysis plan for sleep medicine clinical trials.

Centralised, blinded polysomnography scoring and standardised lab procedures for sleep medicine clinical trials.