Across 215 European CTIS radiopharmaceutical phase 1 - 3 trials authorised in 2024–2026, 50/215 trials (23.3%) listed CRO or CRO-like vendor support. IQVIA was the most active provider, appearing in 19/50 CRO-backed trials (38.0%), followed by Parexel in 14/50 (28.0%), Syneos Health in 12/50 (24.0%), and ICON in 11/50 (22.0%). CRO demand was driven more by European operating footprint than by participant count: 11/12 trials with 7+ countries (91.7%) and 31/47 trials with 11+ sites (66.0%) used CRO support.
The top four providers were IQVIA, Parexel, Syneos Health, and ICON. Because one CTIS trial can list several CROs or delegated service providers, each provider is credited once per supported trial.
| Phase band | CRO-backed trials | CRO rate | Most frequent provider |
|---|---|---|---|
| Phase I | 15/52 | 28.8% | Parexel (9) |
| Phase II | 31/125 | 24.8% | IQVIA (12) |
| Phase III | 21/72 | 29.2% | IQVIA (9) |
Radiopharmaceutical CRO support is concentrated among large global operating platforms and specialist imaging/data vendors. IQVIA led overall and in phase II/III, while Parexel led phase I; this suggests sponsors use broad operational networks for later-phase European expansion and combine them with specialist vendors for imaging, data, and logistics.
CRO use rose sharply once trials crossed multi-country and high-site thresholds. CRO-backed trials had a median of 3 countries and 13 sites, compared with 1 country and 1 site in non-CRO trials.
| Capacity signal | Highest-demand band | CRO-backed / all | CRO rate |
|---|---|---|---|
| Countries | 7+ countries | 11/12 | 91.7% |
| Countries | 4–6 countries | 13/19 | 68.4% |
| Sites | 11+ sites | 31/47 | 66.0% |
| Sites | 5–10 sites | 12/29 | 41.4% |
| Participants | 150–299 participants | 13/31 | 41.9% |
| Participants | 300+ participants | 4/15 | 26.7% |
| Disease breadth | 4+ diseases/indications | 6/21 | 28.6% |
The clearest CRO trigger is European operating complexity. Trials with 7+ countries used CRO support in 11/12 cases (91.7%), and trials with 11+ sites used CRO support in 31/47 cases (66.0%). Participant count was a weaker signal, indicating that EU country/site coordination and CTIS country-level execution create the strongest outsourcing need.
Oncology dominated CRO-backed radiopharmaceutical work, with 33/136 oncology trials (24.3%) using CRO support. By named indication group, prostate cancer contributed the most CRO-backed trials, followed by pancreatic cancer and neuroendocrine tumours.
| Indication group | CRO-backed / all | CRO rate |
|---|---|---|
| Prostate cancer | 14/36 | 38.9% |
| Pancreatic cancer | 11/21 | 52.4% |
| Neuroendocrine tumour | 7/17 | 41.2% |
| Small cell lung cancer | 6/16 | 37.5% |
| Breast cancer | 6/26 | 23.1% |
| Non-small cell lung cancer | 4/12 | 33.3% |
| Renal cell carcinoma | 3/5 | 60.0% |
| Gastric / gastroesophageal cancer | 3/9 | 33.3% |
CRO opportunity is strongest in oncology radiopharmaceutical development, especially prostate cancer and multi-tumour solid oncology programmes. High CRO rates in pancreatic cancer, renal cell carcinoma, and neuroendocrine tumours suggest that sponsors need external support when radiopharmaceutical trials require specialised imaging, dosimetry, biomarker handling, and multi-country CTIS coordination.
The most common outsourced functions were broad clinical operations, data systems, imaging/dosimetry, laboratory/sample services, drug supply/randomisation, and regulatory or CTIS support.
| Function category | Trials | Share of CRO-backed trials | Representative providers |
|---|---|---|---|
| Clinical operations / monitoring / site start-up | 31/50 | 62.0% | IQVIA, Parexel, Syneos, Fortrea, PSI CRO |
| Data systems, EDC, eCOA, IVRS/IWRS | 24/50 | 48.0% | Medidata, Signant, Suvoda, 4G Clinical, Yprime |
| Imaging, dosimetry, PET/SPECT review | 14/50 | 28.0% | Bioclinica, Invicro, Radiopharmaceutical Imaging and Dosimetry |
| Laboratory, biomarkers, PK, sample handling | 18/50 | 36.0% | Labcorp, ICON Laboratory Services, Q2 Solutions, Veeda |
| Drug supply, logistics, kit building, storage | 13/50 | 26.0% | Almac, Creapharm, Azenta, AAA/Novartis vendors |
| Regulatory / CTIS / IRB submissions | 10/50 | 20.0% | WCG Clinical, Asphalion, Parexel, Fortrea |
| Patient engagement, reimbursement, translation | 8/50 | 16.0% | Scout Clinical, Jumo Health, RWS, Welocalize |
Radiopharmaceutical outsourcing is not only full-service CRO management. The dataset shows a modular outsourcing pattern: sponsors combine global CROs with imaging/dosimetry specialists, EDC/eCOA platforms, central laboratories, supply-chain vendors, and CTIS submission support. CTIS/EU submission work becomes especially relevant when trials expand across multiple Member States and Part II country submissions must be coordinated.
France, Spain, Germany, Italy, Poland, the Netherlands, Belgium, and Denmark were the largest country-level operating markets by repeated CTIS participation, planned sites, or participant volume.
| Country | CRO-backed trials | CRO-backed sites / all sites | CRO-backed participants / all participants | CRO-backed site share |
|---|---|---|---|---|
| France | 30/65 | 187/349 | 777/3,371 | 53.6% |
| Spain | 27/48 | 150/226 | 837/2,190 | 66.4% |
| Germany | 25/54 | 189 |