Across 54 CTIS chronic kidney disease phase II–III trials authorised in 2024–2026, 15 trials used at least one CRO or CRO-like operational vendor, equal to 27.8% of the cohort. ICON/PRA was the most active named CRO family, appearing in 5 of 15 CRO-supported trials, followed by IQVIA/Quintiles and Labcorp with 4 each. CRO need was highest in pharma-sponsored, multi-country, 11+ site, and multi-disease trials, making CTIS/EU country activation a stronger outsourcing trigger than trial phase alone.
Among 15 CRO-supported trials, ICON/PRA appeared in 5 trials, IQVIA/Quintiles in 4, Labcorp in 4, and Almac in 3. These four CRO families account for the strongest recurring operational support signal in the CTIS sponsor third-party fields.
The CRO market is not dominated by one provider. ICON/PRA leads, but IQVIA/Quintiles and Labcorp are nearly equal, indicating that CKD trial outsourcing is split between full-service clinical operations, central laboratory, trial technology, and supply-chain specialists.
CRO use rises most clearly with CTIS/EU operational breadth. Trials with 2 or more countries used CROs in 10/24 cases, or 41.7%, compared with 2/25 single-country trials, or 8.0%. Trials with 11+ sites used CROs in 7/18 cases, or 38.9%, compared with 1/16 trials with 1–2 sites, or 6.3%.
The practical CRO trigger is CTIS/EU execution complexity: once a CKD study crosses into multiple Member States and double-digit sites, outsourced country startup, site management, lab logistics, and vendor coordination become materially more common.
CRO use was strongest in metabolic CKD/diabetes-obesity trials at 2/3 trials, or 66.7%, followed by CKD anaemia/renal anaemia and proteinuric/genetic kidney disease, each at 3/5 trials, or 60.0%. ESRD/dialysis trials were frequent, with 14 trials, but had lower CRO use at 2/14, or 14.3%.
| Indication group | CRO-supported | Share |
|---|---|---|
| Metabolic CKD / diabetes-obesity | 2/3 | 66.7% |
| CKD anaemia / renal anaemia | 3/5 | 60.0% |
| Proteinuric / genetic kidney disease | 3/5 | 60.0% |
| Cardio-renal / hypertension CKD | 4/10 | 40.0% |
| ESRD / dialysis kidney failure | 2/14 | 14.3% |
| General CKD | 0/15 | 0.0% |
CRO targeting should prioritise CKD trials with metabolic, anaemia, proteinuric, genetic, cardio-renal, or hypertension language. Pure general CKD and many ESRD/dialysis investigator-led trials show less explicit CRO involvement.
The dataset contains 160 third-party relationships across 28 trials. Central laboratory and bioanalysis was the most common outsourced function, appearing in 17/28 outsourced trials, or 60.7%. Clinical operations/site management followed at 15/28, or 53.6%, then drug supply/QP/documentation at 9/28, or 32.1%.
CKD outsourcing is not only “full-service CRO” work. The dominant functions are lab-heavy, CTIS country/site operations, IMP supply/QP release, documentation, trial technology, patient recruitment, and central adjudication.
Across CTIS country records, the cohort includes 170 trial-country entries and 775 listed sites. Spain, Italy, the Netherlands, Germany, and France account for 465/775 sites, or 60.0% of all listed sites, making these countries the highest-priority markets for EU site activation and Part II country-package execution.
| Country | Trials | Sites | Participants |
|---|---|---|---|
| Spain | 18 | 144 | 1,546 |
| Italy | 19 | 101 | 1,523 |
| Netherlands | 11 | 77 | 1,048 |
| Germany | 20 | 72 | 2,323 |
| France | 14 | 71 | 628 |
For CRO business development, the best CTIS/EU submission angle is not only “CKD experience”; it is proven ability to manage Spain, Italy, Germany, France, and the Netherlands at scale, including Part II documentation, site contracts, lab routing, recruitment materials, and country-level operational follow-through.
The same CTIS fields answer several CRO targeting questions beyond the core ranking. Pharma sponsorship, phase III status, and multi-disease trial design all materially increase the chance that CRO support is explicitly listed.
Pharma/industry sponsors used CROs in 15/31 trials, or 48.4%; academic, healthcare, and research sponsors used CROs in 0/23 trials, or 0.0%.
Phase III trials used CROs in 11/33 cases, or 33.3%, compared with 4/21 phase II trials, or 19.0%.
CRO-supported trials had a median of 9 third parties, compared with 0 in non-CRO trials, showing that CRO presence often travels with a wider outsourced vendor stack.
Trials with 2+ disease terms used CROs in 12/33 cases, or 36.4%, versus 3/21 single-disease trials, or 14.3%.
The strongest practical target profile is a pharma-led phase III CKD trial with more than one disease term, multi-country CTIS submissions, 11+ sites, and outsourced lab or clinical operations needs.
CRO means contract research organisation or CRO-like operational vendor as listed in the CTIS sponsor third-party CRO field. CTIS means Clinical Trials Information System. ESRD means end-stage renal disease. QP means qualified person for medicinal product release. PRO means patient-reported outcome.