Across 157 European CTIS Phase II–III multiple myeloma trials, 85 trials used CRO or CRO-like vendor support, equal to 54.1% of the cohort. IQVIA was the most active support organization, appearing in 28 trials, followed by ICON/PRA in 23, Parexel in 17, and Syneos Health in 16. CRO need rose sharply with EU operational complexity: 32 of 33 trials with 7 or more countries used CRO support.
IQVIA appeared in 28 of 157 trials, equal to 17.8% of all trials and 32.9% of CRO-supported trials. ICON/PRA followed with 23 trials, then Parexel with 17 and Syneos Health with 16. The ranking includes full-service CROs and CTIS-listed specialist vendors because EU submissions often classify operational, laboratory, eClinical, and patient-support providers as delegated third parties.
The CRO market in European multiple myeloma trials is not only a full-service CRO market. IQVIA, ICON/PRA, Parexel, and Syneos show strong operational presence, while Medidata, Labcorp, Endpoint Clinical, Almac, and other specialist vendors reflect the high outsourcing load around eClinical systems, central labs, logistics, and biomarker-heavy myeloma execution.
CRO use increased most clearly with country footprint. Trials spanning 7 or more countries used CRO support in 32 of 33 cases, or 97.0%. The same pattern appeared in large site networks: 32 of 44 trials with 31 or more sites used CRO support, equal to 72.7%.
The strongest CRO trigger is not patient count alone; it is EU footprint. Once a multiple myeloma trial reaches 7 or more countries, CTIS Part II country coordination, site activation, local documents, contracts, vendor oversight, and submission operations become the dominant burden, pushing CRO use close to universal.
Newly diagnosed multiple myeloma trials had the highest CRO-use rate among major indication groups, with 13 of 19 trials using CRO support, or 68.4%. Relapsed/refractory multiple myeloma followed at 38 of 63 trials, or 60.3%. Trials covering 2 or more diseases used CRO support in 35 of 60 cases, compared with 50 of 97 single-disease trials.
CRO need is highest when the trial combines clinical complexity with expansion pressure. Newly diagnosed and relapsed/refractory myeloma studies often require larger site networks, combination regimens, biomarker workflows, and multi-country CTIS submissions, making external operational support more common than in narrower or single-country studies.
The most frequently outsourced functions were central or specialty laboratory and biomarker services, appearing in 96 of 157 trials, or 61.1%. Clinical operations, site support, EU legal/regulatory representation, and submission support appeared in 80 trials, while eClinical systems, electronic clinical outcome assessment, electronic patient-reported outcomes, and data platforms appeared in 68 trials.
The dominant outsourcing pattern is lab and data-heavy rather than purely monitoring-heavy. Multiple myeloma trials frequently require biomarker testing, central labs, MRD-related workflows, eCOA/ePRO systems, supply logistics, and local EU operational support, all of which need to be documented in CTIS submissions and maintained across participating Member States.
Industry-sponsored trials used CRO support in 63 of 82 cases, or 76.8%. Academic, hospital, cooperative-group, or non-profit sponsors used CRO support in 22 of 75 cases, or 29.3%. By modality, CRO use was highest in peptide/protein/enzyme trials at 84.6%, ADC trials at 75.0%, and cell therapy trials at 66.7%.
Sponsor type is one of the clearest adjacent signals. Industry sponsors appear much more likely to delegate CRO/vendor work, while academic and cooperative-group trials more often operate through internal or site-led networks. Advanced modalities also raise the support burden because they add logistics, laboratory, safety, and data-system requirements that must be coordinated across CTIS-submitted country packages.
Spain and France had the widest trial participation, with 76 and 75 trial involvements respectively. Germany had 66 trial involvements and the highest CRO-supported share among the largest countries at 78.8%. Site burden was concentrated in major myeloma centers such as Centre Hospitalier Universitaire De Nantes, Hospital Universitario De Salamanca, Hospital Universitario 12 De Octubre, Centre Hospitalier Universitaire De Lille, and Alexandra Hospital.
For EU submission planning, Spain, France, Germany, Italy, Greece, the Netherlands, Poland, Belgium, and Czechia are the highest-priority operational markets. These countries combine frequent CTIS country participation with dense site networks, making them the clearest targets for CRO feasibility, start-up, site contracting, and local Part II execution support.
There was no clear signal that CRO-supported trials reached first CTIS authorization faster. CRO-supported trials had a median interval of 47 days from initial CTIS submission to first authorization, compared with 43 days for trials without CRO support. The mean values were also close: 62.2 days for CRO-supported trials and 59.3 days for trials without CRO support.
CRO use appears to be driven more by operational scale than by faster first authorization. The main CRO value in this dataset is likely EU execution capacity: handling multi-country CTIS workflows, local Part II packages, site activation, vendor coordination, patient-facing materials, and post-authorization country/site operations.