Therapeutic Areas · Respiratory Diseases
Respiratory programs require specialized functional testing, imaging, biomarker integration and long-term disease monitoring.
Overview
Respiratory programs require specialized functional testing, imaging, biomarker integration and long-term disease monitoring.
Guosa Life Sciences supports respiratory development from early studies through long-term outcome research.
Areas of Expertise
Specialized Capabilities
Why GLS
Our integrated enterprise combines scientific depth, operational excellence and collaborative partnerships to support development across diverse and demanding research environments.
The capability
We support respiratory programs across asthma, COPD, interstitial lung disease, cystic fibrosis and respiratory infection, including the inhaled and device-delivered products that dominate the area.
Respiratory endpoints are equipment-dependent in a way few other areas are. Spirometry quality determines whether a lung function endpoint is interpretable, and equipment variation across sites and countries introduces variance that can exceed the treatment effect being measured.
Regulatory considerations
Spirometry conducted for regulatory purposes is expected to follow recognized standardization criteria, with calibrated equipment, trained and certified operators, defined acceptability and repeatability criteria, and over-reading of tracings by a central facility. Sites that perform spirometry routinely in clinical care frequently do not meet trial standards without additional training and equipment.
Where the product is a drug-device combination, a second regulatory track applies alongside the clinical one. Device performance, handling instructions, dose delivery consistency and human factors evidence are assessed in their own right, and inhaler technique training becomes a study procedure with its own documentation rather than an aspect of routine care.
How an engagement runs
Endpoint selection, spirometry standard and equipment strategy, and device evidence requirements defined before activation.
Equipment provision and calibration, operator training and certification, central over-reading process established.
Ongoing quality review of tracings, retraining where criteria are not met, device handling documented.
Analysis with documented handling of technically unacceptable measurements.
What you receive
An equipment and calibration record across sites. Operator certification documentation. Central over-reading reports. Device handling and training records.
Evidence and context
Our operating assumptions are published rather than asserted. The Future of Clinical Trials in Africa sets out why study performance is increasingly determined by ecosystem maturity rather than site selection, and The Untapped Advantage makes the case that institutions, not regions, are the right unit of qualification. Both are available in full, with executive briefs for readers who want the argument in a shorter form.
Other Therapeutic Areas
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ExploreDiscuss your respiratory diseases program with our multidisciplinary team.