Therapeutic Expertise
Respiratory Medicine
Our respiratory team runs trials across obstructive and interstitial lung disease and pulmonary vascular disease, with the spirometry standardisation and endpoint expertise these programmes require.
Respiratory endpoints — FEV1, 6-minute walk, exacerbation rates and PRO measures — are sensitive to technique and site variation. We standardise spirometry and functional testing, provide central over-read where appropriate, and design endpoint strategies aligned to regulatory guidance.
Addressing common pain points in respiratory medicine clinical trials
Spirometry standardisation
Lung-function measurement varies by device, technique and operator.
We enforce standardised acquisition and central over-read to protect endpoint reliability.
Exacerbation and PRO endpoints
Exacerbation and symptom endpoints are prone to ascertainment and placebo effects.
We define and adjudicate exacerbation endpoints and use validated PROs.
Long-duration retention
Chronic respiratory trials risk dropout over long follow-up.
We use decentralised elements to ease burden and sustain retention.
Resources
Respiratory Medicine clinical trial resources
Navigating the Landscape of COPD Clinical Trials
Design and endpoints in COPD.
The Evolution of Pulmonary Fibrosis Clinical Trials
Trial design in pulmonary fibrosis.
Optimizing Pulmonary Arterial Hypertension Clinical Trials
Endpoint strategy in PAH.
Evidence & insights
Respiratory Medicine white papers
Open-access reports from our physicians and data science teams — free, no sign-in.
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
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