Across 47 European CTIS endometrial/uterine cancer Phase II & Phase III trials, 30 trials used at least one CRO or CRO-like outsourced support provider, equal to 63.8%. IQVIA was the most active named CRO, appearing in 9 of 47 trials, followed by Parexel / Perceptive, ICON / PRA, and Clario / BioClinica / ERT at 7 trials each. CRO demand was strongest where CTIS execution complexity increased: adaptive designs, 31+ site footprints, 9+ country submissions, and 300–599 global target sample sizes.
IQVIA appeared in 9 of 47 trials, equal to 19.1%. Parexel / Perceptive, ICON / PRA, and Clario / BioClinica / ERT each appeared in 7 of 47 trials, equal to 14.9% each.
The market is not dominated by a single CRO. IQVIA leads, but the next tier is tightly clustered, suggesting sponsors split European CTIS execution across global CROs, imaging vendors, digital trial vendors, and lab-heavy specialist providers.
CRO use was highest in adaptive trials at 12 of 12 trials, or 100.0%. Among operational-capacity bands, 31+ site trials used CROs in 9 of 10 cases, or 90.0%, while 9+ country CTIS footprints used CROs in 8 of 9 cases, or 88.9%.
| Capacity / complexity signal | CRO-supported trials | Rate |
|---|---|---|
| Adaptive design | 12 / 12 | 100.0% |
| 31+ European sites | 9 / 10 | 90.0% |
| 300–599 global target sample | 9 / 10 | 90.0% |
| 9+ CTIS countries | 8 / 9 | 88.9% |
| 300+ European participants | 4 / 5 | 80.0% |
| 16–30 European sites | 9 / 12 | 75.0% |
CRO need is most visible when sponsors must coordinate multi-country CTIS submissions, many site contracts, participant logistics, and adaptive dose-escalation or expansion operations. The practical threshold appears around 9+ countries, 16+ sites, and 150+ European participants.
Basket or multi-tumour trials including endometrial cancer accounted for 38 of 47 trials, with CRO support in 24 of 38, or 63.2%. ADC-containing trials were the strongest modality signal: 13 of 14 ADC trials used CRO support, equal to 92.9%.
Endometrial cancer outsourcing is not only disease-driven; it is modality- and assay-driven. ADC trials, biomarker-stratified trials, and basket protocols create demand for central lab, imaging, PK/ADA, IRT, CTIS country coordination, and site-startup support.
The most frequent outsourced function was central lab / biomarker / PK-ADA testing, present in 29 of 47 trials, or 61.7%. Clinical operations, regulatory, and CTIS submission support appeared in 27 of 47 trials, or 57.4%.
Outsourcing is concentrated around execution-critical functions: biomarker testing, CTIS regulatory operations, imaging review, digital trial infrastructure, and IMP logistics. This matches the operational profile of modern endometrial cancer trials, especially ADC and biomarker-selected studies.
Spain appeared in 36 trial-country entries with 245 sites and 1,685 participant allocations. France followed with 27 trial-country entries, 220 sites, and 1,564 participant allocations.
For CROs targeting European endometrial cancer trials, Spain and France are the strongest site-activation and CTIS country-submission markets, followed by Italy, Germany, Belgium, and Poland.
The existing data also answers which trial type, phase, modality, and CRO footprint creates the strongest outsourcing signal.
CTIS means Clinical Trials Information System. EDC means electronic data capture. eCOA means electronic clinical outcome assessment. IRT means interactive response technology. eTMF means electronic trial master file. IMP means investigational medicinal product. QP means qualified person. PK means pharmacokinetics. ADA means anti-drug antibodies.