Across 488 pediatric Phase 3 CTIS trials from 2024–2026, CROs or operational vendors were listed in 331 trials, equal to 67.8%. PPD / Thermo Fisher Clinical Research, ICON / PRA Health Sciences, and IQVIA / Quintiles were the most frequently named organizations. CRO use was driven more by CTIS country footprint and site-network complexity than by participant volume alone.
CROs or operational vendors were named in 216 of 319 trials in 2024, or 67.7%; 85 of 124 trials in 2025, or 68.5%; and 30 of 45 trials in 2026, or 66.7%. Across all three years, CRO-supported trials represented 331 of 488 trials, or 67.8%.
CRO involvement was not a one-year artifact. The annual rate stayed within a narrow 1.8 percentage-point range, indicating that outsourcing is a consistent execution model for pediatric Phase 3 trials in Europe.
Among 331 CRO-supported pediatric Phase 3 trials, PPD / Thermo Fisher Clinical Research appeared in 101 trials, or 30.5%; ICON / PRA Health Sciences in 97 trials, or 29.3%; and IQVIA / Quintiles in 95 trials, or 28.7%. The CTIS CRO field also included operational vendors such as Clario, Medidata, Suvoda, and Signant Health.
The leading CRO signal is concentrated in large global providers, but the broader vendor mix shows that pediatric Phase 3 outsourcing frequently combines clinical operations with technology, central laboratory, imaging, randomisation, and supply-chain partners.
CRO use was lowest in single-country pediatric Phase 3 trials: 28 of 122 trials, or 23.0%. It increased to 59 of 87 trials across 2–3 countries, or 67.8%, then reached 110 of 127 trials across 4–6 countries, or 86.6%, and 134 of 152 trials across 7+ countries, or 88.2%.
The clearest outsourcing threshold is geographic. Once a pediatric Phase 3 program needs 4 or more EU/EEA CTIS country submissions, CRO utilization becomes the norm rather than the exception.
CRO use was 48 of 108 trials with 1–5 sites, or 44.4%. It increased to 92 of 135 trials with 6–15 sites, or 68.1%, then 121 of 155 trials with 16–40 sites, or 78.1%, and 55 of 69 trials with 41+ sites, or 79.7%.
The site threshold appears around 16+ sites. At that point, pediatric trials typically require centralized startup, contracting, monitoring, vendor coordination, and country-level CTIS support.
CRO use was high even in smaller pediatric trials: 134 of 180 trials with 50 or fewer participants used CROs, or 74.4%. Trials with 51–200 participants used CROs in 126 of 176 cases, or 71.6%, while larger participant bands showed lower rates: 54 of 108 trials with 201–1,000 participants, or 50.0%, and 8 of 14 trials above 1,000 participants, or 57.1%.
Pediatric CRO need is not simply a large-enrollment problem. Smaller rare-disease and specialist pediatric trials still require CROs when country footprint, site specialization, central services, or CTIS documentation complexity is high.
Single-disease trials used CROs in 242 of 327 cases, or 74.0%. Trials listing 2 diseases used CROs in 75 of 121 cases, or 62.0%, while trials listing 3 or more diseases used CROs in 14 of 40 cases, or 35.0%.
The CRO signal is strongest in focused pediatric development programs, especially where sponsors need repeatable execution for one specific indication across multiple EU countries and sites.
At disease level, CRO concentration was strongest in ulcerative colitis, Crohn’s disease, atopic dermatitis, hereditary angioedema, and sickle cell disease. Ulcerative colitis had CRO support in 13 of 14 trials, Crohn’s disease in 12 of 13, atopic dermatitis in 12 of 13, hereditary angioedema in 9 of 9, and sickle cell disease in 7 of 8.
The highest disease-level CRO concentration appears where pediatric trials combine specialist sites, central services, long follow-up, and multi-country regulatory execution. These indications are strong markers of CRO demand in pediatric Phase 3 development.
CROs were listed in 120 of 147 orphan pediatric Phase 3 trials, or 81.6%. In non-orphan pediatric Phase 3 trials, CROs were listed in 211 of 341 trials, or 61.9%.
Orphan designation is a strong CRO-use signal. These studies often combine small patient pools with specialist site identification, cross-border activation, and intensive regulatory coordination under CTIS.
Among 331 CRO-supported trials, clinical operations or regulatory CRO functions appeared in 308 trials, or 93.1%. Central lab or bioanalysis services appeared in 191 trials, or 57.7%, while digital trial systems, including eCOA or EDC-type services, appeared in 137 trials, or 41.4%.
The outsourcing stack is operational first, then specialized. Most CRO-supported pediatric Phase 3 trials require clinical operations or regulatory execution, while central lab, eCOA, EDC, randomisation, imaging, and supply-chain services form the second layer of outsourced capacity.
Across CRO-supported pediatric Phase 3 trials, there were 2,025 trial-country occurrences. Spain contributed 248 occurrences, Italy 220, Germany 216, France 189, and Poland 185. Together, these five countries accounted for 1,058 of 2,025 CRO-supported trial-country occurrences, or 52.2%.
The leading CTIS country footprint points to where pediatric CRO capability matters most: Spain, Italy, Germany, France, and Poland. These markets concentrate site activation, local submissions, translations, contracting, and operational execution for CRO-supported pediatric Phase 3 trials.
CRO means contract research organization. CTIS means Clinical Trials Information System, the EU clinical trial submission and authorization platform. EU/EEA means European Union / European Economic Area. EDC means electronic data capture. eCOA means electronic clinical outcome assessment. RTSM means randomisation and trial supply management.