Across 45 European CTIS heart failure Phase II and Phase III trials authorized from 2024 to 2026, 23 trials listed contract research organization (CRO) or outsourced vendor support, equal to 51.1%. ICON and IQVIA were the most active named CRO/provider groups, each appearing in 7 trials. CRO need was strongest when trials crossed 6 or more countries, where 12 of 13 trials used external support, and when trials reached 21 or more sites, where 13 of 18 trials used external support.
ICON and IQVIA were the leading provider groups, each appearing in 7 of 45 trials, equal to 15.6% of the total cohort and 30.4% of CRO-supported trials. Medidata, Suvoda, and the Fortrea / PPD / PRA group each appeared in 4 trials, equal to 8.9% of all trials.
The heart failure CRO market is not only full-service CRO led. ICON and IQVIA led overall activity, but digital systems, randomization, imaging, laboratories, supply chain, and patient-support vendors also appeared repeatedly, showing that sponsors often outsource modular CTIS execution functions rather than a single end-to-end operating model.
CRO support increased most sharply with CTIS geographic and site complexity. Among trials with 6 or more countries, 12 of 13 were CRO-supported, equal to 92.3%. Among trials with 21 or more sites, 13 of 18 were CRO-supported, equal to 72.2%. Participant volume alone was less predictive: trials with 1,000 or more participants were 8 of 15 CRO-supported, equal to 53.3%.
The clearest outsourcing trigger is not patient count by itself. CRO need rises when sponsors must coordinate EU country-level CTIS submissions, site activation, contracting, monitoring, and operational governance across multiple countries and site networks.
CRO use was highest in mixed or more operationally complex heart failure subgroups. Pulmonary hypertension plus heart failure had CRO support in 3 of 3 trials, obesity plus heart failure in 2 of 2 trials, HFmrEF in 5 of 6 trials, HFpEF in 8 of 10 trials, and HFrEF in 7 of 9 trials.
| Indication group | CRO use | Sites | Participants |
|---|---|---|---|
| Pulmonary hypertension + heart failure | 3 / 3 · 100.0% | 110 | 583 |
| Obesity + heart failure | 2 / 2 · 100.0% | 0 | 5,887 |
| HFmrEF | 5 / 6 · 83.3% | 116 | 11,048 |
| HFpEF | 8 / 10 · 80.0% | 234 | 12,949 |
| HFrEF | 7 / 9 · 77.8% | 325 | 8,443 |
| General / chronic heart failure | 8 / 12 · 66.7% | 196 | 9,812 |
HFpEF, HFmrEF, HFrEF, pulmonary hypertension, and obesity-overlap trials are the strongest CRO opportunity zones because they combine large cardiology populations with multi-country feasibility, specialist site networks, imaging, biomarkers, eCOA, and CTIS submission coordination.
The most frequently outsourced functions were eCOA, EDC, RTSM, IWRS, and digital trial systems in 14 of 45 trials, followed by central laboratory, bioanalysis, sample management, and pharmacokinetic services in 13 of 45 trials. Clinical operations or full-service CRO support appeared in 11 of 45 trials, and imaging, ECG, ECHO, or adjudication appeared in 10 of 45 trials.
The highest-frequency outsourcing areas map directly to operational friction in EU heart failure trials: digital systems for patient-reported data and randomization, laboratories and sample logistics for biomarker-heavy protocols, imaging and ECG/ECHO workflows for cardiology endpoints, and CTIS/EU submission support for multi-country activation.
CRO support increased materially after 2024. In 2024, 6 of 23 trials were CRO-supported, equal to 26.1%. In 2025, 13 of 17 trials were CRO-supported, equal to 76.5%. In 2026, 4 of 5 trials were CRO-supported, equal to 80.0%. By phase, Phase III trials had CRO support in 15 of 27 trials, while Phase II trials had CRO support in 8 of 18 trials.
CRO reliance was higher in the later CTIS window and higher in Phase III than Phase II. For commercial teams, the clearest demand pocket is not simply “heart failure,” but Phase III and late-window CTIS programs with multinational footprint and multiple operational vendors.
Spain, Poland, Germany, France, and Italy were the largest operational markets by reported site footprint. Spain contributed 173 sites across 18 trials, Poland 155 sites across 19 trials, Germany 104 sites across 19 trials, France 101 sites across 8 trials, and Italy 71 sites across 10 trials.
| Country | Sites | Trials | CRO-supported trials |
|---|---|---|---|
| Spain | 173 | 18 | 16 |
| Poland | 155 | 19 | 16 |
| Germany | 104 | 19 | 12 |
| France | 101 | 8 | 6 |
| Italy | 71 | 10 | 8 |
Spain, Poland, Germany, France, and Italy are the clearest feasibility and start-up markets for European heart failure CRO services. In CTIS terms, these countries create recurring Part II submission, ethics/regulatory coordination, site activation, contracting, and monitoring demand.
Across 161 CTIS country-level entries, the median processing time from earliest CTIS Part II submission to latest decision or authorization was 55 days. CRO-associated country entries had a median of 54 days, while non-CRO country entries had a median of 71.5 days.
CTIS/EU submission support is most commercially relevant when trials expand beyond one country. The dataset shows that 12 of 13 trials with 6 or more countries used CRO/vendor support, making country activation and Part II coordination a central heart failure outsourcing trigger.
The same CTIS dataset also answers sponsor-type, phase, country-priority, and design-complexity questions with numeric evidence.
Yes. Pharma and biotech sponsors used CRO support in 19 of 23 trials, equal to 82.6%, versus 4 of 21 academic or hospital-sponsored trials, equal to 19.0%.
Yes. Phase III trials used CRO support in 15 of 27 trials, equal to 55.6%, versus 8 of 18 Phase II trials, equal to 44.4%.
Spain, Poland, Germany, France, and Italy ranked highest by site footprint, with 173, 155, 104, 101, and 71 aggregated sites respectively.
Among CRO-supported trials, 20 of 23 were randomized, equal to 87.0%, and 3 of 23 included single/multiple or escalation-dose combined designs, equal to 13.0%.
CTIS means Clinical Trials Information System. In this report, CTIS/EU submission refers to country-level Part II submission, decision, and authorization metadata.
CRO support means the trial sponsor variable listed a CRO or outsourced provider in the CRO-present field.
HFpEF, HFmrEF, and HFrEF mean heart failure with preserved, mildly reduced, and reduced ejection fraction.
eCOA, EDC, RTSM/IWRS, and DMC mean electronic clinical outcome assessment, electronic data capture, randomization/trial supply management or interactive response technology, and data monitoring committee.