Across 86 unique CTIS-authorized ovarian, fallopian tube, and primary peritoneal cancer Phase II/III trials in Europe, CROs or CRO-like third parties appear in 51 trials, equal to 59.3%. CRO need rises sharply with geographic and site complexity: 15 of 16 trials with 8+ countries use CROs, and 12 of 14 trials with 51+ sites use CROs. ICON/PRA and IQVIA/Q2 Solutions are the most active CRO groups, each appearing in 15 trials.
ICON/PRA and IQVIA/Q2 Solutions are the leading CRO groups, each supporting 15 of the 51 CRO-supported trials, equal to 29.4%. Clario/Bioclinica/imaging vendors follow with 11 trials, while Almac and PPD/Thermo Fisher each appear in 10 trials.
The CRO market is not dominated by one provider. CTIS sponsor disclosures show a mixed full-service and specialist vendor model: ICON/PRA and IQVIA lead overall, while Clario/Bioclinica, Medidata, Almac, and PPD/Thermo Fisher appear frequently as imaging, data, laboratory, and supply partners.
CRO use increases most clearly with country and site footprint. CROs are used in 15 of 16 trials with 8+ European countries and in 12 of 14 trials with 51+ sites. Participant volume is less linear, but global target sample size above 300 patients still shows high CRO reliance: 17 of 23 trials.
For ovarian cancer sponsors, CRO need becomes structurally high once CTIS submission work spans 4+ countries or 21+ sites. Country-count complexity is the strongest signal because it multiplies Part II country submissions, site contracting, local documents, and national authorization workflows.
Platinum-resistant ovarian cancer shows the highest CRO reliance among recurring disease segments: 8 of 9 trials use CROs, equal to 88.9%. Basket or multi-tumor trials that include ovarian cancer also show high outsourcing, with CROs in 21 of 28 trials, equal to 75.0%.
CRO demand is highest where trials are operationally harder: platinum-resistant disease, basket trials, and biomarker-defined advanced settings. These trials typically require broader country activation, specialist site networks, central testing, imaging review, and tighter CTIS submission coordination.
ADC trials show the highest CRO reliance by modality: 21 of 22 ADC-containing trials use CROs, equal to 95.5%. CRO use is also high in dose-escalation or dose-optimization designs, adaptive trials, orphan-drug trials, and biomarker-stratified trials.
The strongest non-geographic CRO trigger is technical trial complexity. ADC, biomarker, adaptive, and dose-optimization designs require central testing, safety monitoring, imaging review, drug logistics, and CTIS documentation discipline across multiple EU/EEA countries.
Among the 51 CRO-supported trials, central laboratory or biomarker testing is the most common outsourced function, appearing in 41 trials, equal to 80.4%. Digital systems and data capture appear in 32 trials, central imaging or adjudication in 29 trials, and broad CRO study conduct in 28 trials.
The most visible outsourced work is not only classic monitoring. In ovarian cancer CTIS submissions, outsourcing clusters around central lab and biomarker infrastructure, digital systems, central imaging, and broad study-conduct vendors. This fits the ovarian pipeline’s reliance on ADCs, biomarker selection, imaging endpoints, and multi-country EU submissions.
Spain, Italy, France, Belgium, and Germany are the largest recurring CTIS geographies by trial-country entries. CRO-supported trials represent 40 of 50 Spanish entries, 34 of 40 French entries, 31 of 37 Belgian entries, 29 of 42 Italian entries, and 22 of 32 German entries.
| Country | CRO entries | Share | Site load |
|---|---|---|---|
| Spain | 40 / 50 | 80.0% | 386 |
| Italy | 29 / 42 | 69.0% | 395 |
| France | 34 / 40 | 85.0% | 468 |
| Belgium | 31 / 37 | 83.8% | 138 |
| Germany | 22 / 32 | 68.8% | 287 |
| Poland | 19 / 21 | 90.5% | 108 |
| Czechia | 15 / 17 | 88.2% | 74 |
The CRO opportunity is concentrated in the large EU ovarian cancer trial geographies: France, Italy, Spain, Germany, Belgium, Poland, and Czechia. These countries combine high site load with frequent CRO-supported CTIS Part II country participation, making them priority markets for submission, startup, site contracting, monitoring, and central-service support.
Across 331 country-level CTIS Part II authorization rows with processing-time values, CRO-supported entries have a median processing time of 95.5 days, compared with 342 days for non-CRO-supported entries. This is an observed association, not a causal estimate.
CRO-supported ovarian cancer submissions are heavily represented in the faster observed CTIS country rows. The operational takeaway is that CRO involvement is most relevant when sponsors need coordinated, repeatable Part II execution across many countries rather than single-country submission support.
The clearest CRO-demand signals in ovarian cancer Phase II/III trials are multi-country CTIS footprint, high site count, ADC modality, biomarker selection, adaptive or dose-optimization design, orphan status, and platinum-resistant disease.
CRO = contract research organization. CTIS = Clinical Trials Information System. ADC = antibody-drug conjugate. EDC = electronic data capture. eCOA/ePRO = electronic clinical outcome assessment / electronic patient-reported outcome. eTMF/CTMS = electronic trial master file / clinical trial management system.