Across 89 CTIS melanoma Phase II/III trial records, CRO or specialist vendor support appears in 35 trials, or 39.3%. CRO-supported trials carry a much larger operational footprint: 211 of 311 country-level CTIS submissions, 1,072 of 1,447 European sites, and 6,917 of 13,070 planned geography participants. Parexel is the most frequent CRO/vendor group with 11 supported trials, followed by ICON and PPD/Thermo Fisher with 10 each.
Parexel appears in 11 of 89 trials, while ICON and PPD/Thermo Fisher each appear in 10. Because CTIS CRO fields include both full-service CROs and specialist vendors, the ranking below should be read as CRO/vendor support intensity rather than only full-service outsourcing.
| Group | Trials | Countries | Sites | Planned participants |
|---|---|---|---|---|
| Parexel | 11 | 56 | 321 | 2,456 |
| ICON | 10 | 89 | 489 | 4,241 |
| PPD / Thermo Fisher | 10 | 74 | 314 | 1,950 |
| Medidata | 5 | 34 | 172 | 1,599 |
| Almac | 5 | 36 | 160 | 1,847 |
| IQVIA | 4 | 25 | 147 | 697 |
| WCG Clinical | 3 | 26 | 168 | 457 |
| Fortrea | 3 | 21 | 110 | 1,103 |
| Suvoda | 3 | 23 | 83 | 836 |
The active-provider market is concentrated: Parexel, ICON and PPD/Thermo Fisher appear across 23 of the 35 CRO-supported trials. ICON carries the largest site and country footprint, covering 489 sites and 89 country-level CTIS submissions.
CRO use rises sharply once melanoma trials become multinational, site-heavy, paediatric, orphan-designated, digitally recruited, or Phase II/III transition studies. The strongest scale signals are ≥5 countries, ≥20 sites, and ≥300 planned participants.
CRO need is most visible when EU execution becomes operationally distributed: CRO-supported trials have a median of 5 countries and 22 sites, compared with 1 country and 2.5 sites in trials without CRO support.
CRO-supported trials account for 67.8% of country-level CTIS submissions and 74.1% of European sites. Spain, Germany, Italy and France represent the largest CRO-supported site loads.
| Country | CRO-supported sites | Site share | CRO CTIS country instances |
|---|---|---|---|
| Spain | 223 | 77.2% | 28/37 |
| Germany | 212 | 79.4% | 23/34 |
| Italy | 175 | 80.6% | 23/36 |
| France | 171 | 74.7% | 25/35 |
| Poland | 49 | 83.1% | 16/23 |
| Belgium | 43 | 89.6% | 16/21 |
CRO need is highest where CTIS Part II and local site execution must scale across many Member States. Germany, Spain, Italy and France are the most important EU submission and site-startup markets for melanoma outsourcing.
CRO use is highest in BRAF-mutated melanoma, basket or multi-tumour studies including melanoma, and advanced or metastatic melanoma. Early-stage/adjuvant melanoma has a large planned population but lower observed CRO use.
| Indication group | CRO trials | Share | Planned participants |
|---|---|---|---|
| BRAF-mutated melanoma | 3/5 | 60.0% | 718 |
| Basket / multi-tumour including melanoma | 13/24 | 54.2% | 4,153 |
| Advanced / metastatic melanoma | 7/15 | 46.7% | 3,284 |
| Uveal / choroidal melanoma | 5/12 | 41.7% | 1,580 |
| Melanoma unspecified / mixed | 4/12 | 33.3% | 1,169 |
| Early-stage / adjuvant melanoma | 2/18 | 11.1% | 3,779 |
The strongest CRO signal is not only disease volume. It appears where melanoma trials require biomarker-defined populations, basket-trial coordination, complex CTIS country dossiers, or multi-country specialist-site activation.
Outsourcing is most frequent for central lab/biomarker/PK testing and trial technology, each appearing in 25 or 23 of 89 trial records depending on the function category. Regulatory, ethics and CTIS submission support appears in 14 of 89 trials.
Melanoma outsourcing is highly technical. Central lab, biomarker, PK, imaging, eCOA/ePRO and trial-system support appear more often than standalone patient recruitment support, which is present in 3 of 89 trials.
The existing CTIS data can also answer whether CRO use is more associated with geography, site burden, sample size, recruitment duration, or regulatory complexity.
CRO-supported trials have a median of 5 countries versus 1 country without CRO support.
CRO-supported trials have a median of 22 sites versus 2.5 sites without CRO support.
CRO-supported trials have a median planned sample size of 188 versus 60 without CRO support.
Median recruitment window is 54 months with CRO support versus 57 months without CRO support.
The data suggests CRO demand in melanoma is driven more by CTIS geography, site activation, participant scale and technical outsourcing than by recruitment duration alone.
CRO/vendor support: third-party organizations recorded in CTIS CRO fields, including full-service CROs, central labs, imaging vendors, technology vendors and specialist operational providers.
CTIS: Clinical Trials Information System, the EU portal used for clinical trial submissions and Member State authorization workflows.
EDC/eTMF/CTMS/IRT/RTSM: electronic data capture, electronic trial master file, clinical trial management system, interactive response technology and randomization/trial supply management systems.
eCOA/ePRO: electronic clinical outcome assessment and electronic patient-reported outcome systems.