Across 119 European respiratory Phase III trials authorized through CTIS in 2024–2026, CROs were named in 41 trials, equal to 34.5% of the cohort. CRO demand concentrated in operationally complex trials: 18 of 21 trials with 50+ sites used CRO support, and 11 of 12 trials spanning 11+ countries used CROs. PPD / Thermo Fisher, IQVIA, and ICON / PRA were the most recurrent CRO groups, while the most outsourced functions were eClinical systems, central laboratory or biomarker work, IMP logistics, and patient-support operations.
CRO support was present in 20 of 68 respiratory Phase III trials in 2024, 12 of 35 in 2025, and 9 of 16 in 2026. The CRO-use rate therefore increased from 29.4% in 2024 to 56.3% in 2026.
The 2026 cohort shows a clear move toward outsourced execution. In CTIS respiratory Phase III submissions, CRO demand is no longer limited to the largest legacy studies; it is increasingly visible in newly authorized respiratory development programs.
Among the 41 CRO-supported respiratory Phase III trials, PPD / Thermo Fisher appeared in 15 trials, IQVIA in 13, ICON / PRA in 8, Labcorp in 7, and Clario / eRT / Bioclinica in 7. Because a single trial can name multiple CROs or specialist providers, the ranking reflects CRO-group presence rather than exclusive trial ownership.
The most active CRO groups combine global trial operations with specialist respiratory execution infrastructure. Their presence is strongest in trials that need central labs, respiratory-function reading, eCOA, interactive response technology, supply logistics, and EU country activation through CTIS.
CRO use was rare in single-country trials, where only 3 of 63 trials used a CRO. It became dominant in larger European footprints: 16 of 21 trials with 6–10 countries and 11 of 12 trials with 11+ countries used CRO support. The site-count threshold was even clearer: 18 of 21 trials with 50+ sites were CRO-supported.
The strongest CRO trigger is not respiratory therapy area alone; it is European execution complexity. Once a Phase III respiratory trial crosses roughly 6 countries or 50 sites, the CTIS operational workload usually requires outsourced activation, site management, vendor coordination, and country-level execution support.
The median CRO-supported respiratory Phase III trial involved 7 countries, 43 sites, 249 participants, and 9 third parties. The median non-CRO trial involved 1 country, 11.5 sites, 193.5 participants, and no third parties.
CRO support is most strongly associated with multi-vendor operating models. The jump from 0 to 9 median third parties shows that outsourcing demand often reflects the need to coordinate laboratories, technology vendors, logistics providers, imaging or respiratory assessment specialists, and patient-support services under one EU submission framework.
Among indication groups with at least four trials, CRO use was highest in obstructive sleep apnoea, where 5 of 5 trials used CROs; chronic rhinosinusitis with nasal polyps, where 4 of 4 used CROs; idiopathic or progressive pulmonary fibrosis, where 4 of 5 used CROs; interstitial lung disease, where 3 of 6 used CROs; and asthma, where 6 of 13 used CROs.
The highest CRO-demand indications are not simply the most frequent diseases. They are indications that require distributed specialist sites, patient-identification support, device or respiratory-function workflows, eCOA, imaging, central reading, or complex site activation across multiple EU countries.
Small molecules appeared in 71 trials and accounted for 21 CRO-supported trials, a CRO-use rate of 29.6%. Monoclonal antibodies appeared in 31 trials with 15 CRO-supported trials, equal to 48.4%, while peptide, protein, or enzyme therapies appeared in 15 trials with 7 CRO-supported trials, equal to 46.7%.
Small molecules drive the largest absolute trial volume, but biologics and peptide or protein programs show stronger outsourcing intensity. This points to additional vendor demand around sample handling, biomarker workflows, safety monitoring, device-enabled assessment, and specialist trial operations.
Among 41 CRO-supported trials, eClinical systems such as IRT, EDC, eCOA or RTSM appeared in 29 trials; central laboratory, biosample or biomarker services appeared in 27; IMP logistics, depot, QP release or supply-chain services appeared in 21; and patient recruitment, retention or reimbursement support appeared in 20.
Respiratory Phase III outsourcing is heavily systems-and-measurement driven. The demand pattern is strongest where EU trials need CTIS-ready country documents, site activation, central lab logistics, respiratory-function standardization, eCOA capture, randomization systems, and patient-support services.
At the trial level, the median interval from initial CTIS submission to first authorization was 112 days for CRO-supported trials versus 91.5 days for non-CRO trials. At country level, where Part II country processing times were available, CRO-supported country entries had a median processing time of 39 days versus 97 days for non-CRO country entries.
The trial-level CTIS interval is longer for CRO-supported trials because these programs are typically larger and more complex. The country-level Part II signal points in the opposite direction: once country submissions are active, CRO-supported execution appears concentrated in more structured, faster-moving country operations.
Digital or remote recruitment was present in 22 of 41 CRO-supported trials, equal to 53.7%, compared with 7 of 78 non-CRO trials, equal to 9.0%. Registry, advocacy or patient-association recruitment was present in 6 of 41 CRO-supported trials versus 5 of 78 non-CRO trials.
CRO-supported respiratory trials are more likely to use patient-facing recruitment infrastructure, especially digital materials, direct-to-patient workflows, online screeners, patient-association materials, or reimbursement and travel-support vendors. This is most relevant for chronic respiratory indications where eligible patients are dispersed across specialist sites.
CRO means contract research organization or named outsourced clinical-trial service provider. CTIS means Clinical Trials Information System, the EU platform used for clinical trial submissions and authorizations. IMP means investigational medicinal product. IRT, IWRS and RTSM refer to randomization, treatment assignment and supply-management systems. eCOA and ePRO refer to electronic clinical outcome assessment and electronic patient-reported outcome capture.
For respiratory Phase III sponsors planning European CTIS submissions, CRO need is most predictable when a trial combines multiple countries, 50+ sites, specialist respiratory assessments, patient-facing recruitment, central lab or imaging vendors, and complex IMP logistics. CRO selection should therefore be matched to EU country activation capacity and respiratory-specific vendor orchestration, not only broad therapeutic-area experience.