Across 66 CTIS-authorized obesity/overweight Phase II and III trials in Europe, CRO or outsourced vendor support appears in 48 trials, equal to 72.7%. IQVIA is the most active CRO/vendor family, supporting 35 of 66 trials, followed by ICON in 24 trials and 4G Clinical in 12 trials. CRO demand is strongest in operationally complex trials: 17 of 18 trials with 26+ sites, 26 of 27 trials with 4+ countries, and 15 of 16 trials enrolling 151–300 participants used CRO support.
IQVIA appears in 35 of 66 trials, equal to 53.0%, while ICON appears in 24 of 66 trials, equal to 36.4%. The next tier is more specialized: 4G Clinical supports 12 trials, Bioclinica/Clario 10, Labcorp 9, Celerion 7, and Parexel 6.
Obesity CRO demand is not concentrated only in “main CRO” relationships. The leading names also appear through lab, eCOA, imaging, randomisation, and patient-support roles, which means the active CRO landscape is broader than traditional full-service outsourcing.
All 14 trials with 6 or more countries used CRO support, and 17 of 18 trials with 26+ sites used CRO support. By contrast, only 5 of 19 single-country trials and 5 of 19 trials with 1–5 sites used CRO support.
| Capacity band | CRO use | Rate |
|---|---|---|
| 6–10 countries | 11/11 | 100.0% |
| 11+ countries | 3/3 | 100.0% |
| 26+ sites | 17/18 | 94.4% |
| 11–25 sites | 17/18 | 94.4% |
| 151–300 participants | 15/16 | 93.8% |
| 1 country | 5/19 | 26.3% |
| 1–5 sites | 5/19 | 26.3% |
The clearest outsourcing trigger is not simply trial phase; it is operational spread. Once an obesity trial needs multiple EU/EEA CTIS submissions, many sites, and participant-scale delivery, sponsor reliance on CRO/vendor infrastructure becomes near-universal.
The dataset contains 195 named CRO/vendor responsibility assignments. Central or special laboratory, pharmacokinetic, and biomarker work accounts for 54 of 195 assignments, equal to 27.7%. eCOA/ePRO and translation work appears in 15 assignments, RTSM/IWRS/IXRS in 13, main CRO or monitoring operations in 12, and patient recruitment/retention/payment/DCT support in 12.
Obesity trials outsource heavily around measurement infrastructure: labs, PK, biomarkers, eCOA, imaging, ECG, wearables, and randomisation systems. This fits an obesity pipeline where metabolic, cardiovascular, renal, hepatic, and patient-reported endpoints often require specialist vendors beyond standard site monitoring.
The obesity Phase II/III CTIS footprint spans 21 countries, 247 country-trial entries, 1,398 listed sites, and 19,824 planned participants. Germany has the most sites with 241, followed by Poland with 211 and Spain with 197. Poland has the highest participant allocation with 2,804, followed by Germany with 2,790 and the Netherlands with 2,272.
| Country | Sites | Participants | CRO-supported country entries |
|---|---|---|---|
| Germany | 241 | 2,790 | 31/35 |
| Poland | 211 | 2,804 | 25/26 |
| Spain | 197 | 1,524 | 24/25 |
| Italy | 111 | 762 | 15/17 |
| Czechia | 96 | 1,279 | 16/17 |
| Bulgaria | 69 | 914 | 13/13 |
| Belgium | 69 | 539 | 12/13 |
| France | 65 | 423 | 10/11 |
| Denmark | 62 | 1,264 | 15/20 |
| Hungary | 61 | 657 | 11/11 |
Germany, Poland, and Spain are the clearest obesity trial execution markets. They combine high site counts with high CRO-supported CTIS country activity, making them the strongest targets for EU submission support, site activation, monitoring, patient operations, and vendor coordination.
Pure obesity/overweight trials make up 30 of 66 trials, with CRO support in 19 of 30. Type 2 diabetes overlap appears in 13 trials, with CRO support in 12 of 13. Sleep apnoea, osteoarthritis, chronic kidney disease, heart failure, inflammatory bowel disease, rare/genetic obesity, and cardiovascular-risk segments all show 100.0% CRO use in the available cohort.
| Disease segment | CRO use | Participants |
|---|---|---|
| Obesity/overweight only | 19/30 | 9,177 |
| Type 2 diabetes | 12/13 | 3,786 |
| Osteoarthritis | 4/4 | 1,724 |
| Obstructive sleep apnoea | 4/4 | 527 |
| Chronic kidney disease | 3/3 | 410 |
| Heart failure | 2/2 | 3,618 |
| Inflammatory bowel disease | 2/2 | 363 |
| Rare/genetic obesity | 2/2 | 87 |
The strongest CRO need appears where obesity trials become multi-system disease programs. Diabetes, renal, sleep, cardiovascular, liver, and musculoskeletal overlaps increase operational complexity because sponsors need broader site networks, specialist assessments, central labs, device data, and more complex CTIS country coordination.
Pharmaceutical companies sponsor 61 of 66 trials and use CRO support in 48 of those 61 trials, equal to 78.7%. Novo Nordisk sponsors 22 trials and uses CRO support in 18; Eli Lilly sponsors 14 trials and uses CRO support in 13. Educational institutions and hospital/clinic sponsors account for 5 trials combined and show no CRO-present entries in this cohort.
| Sponsor | Trials | CRO-supported | Third-party entries |
|---|---|---|---|
| Novo Nordisk A/S | 22 | 18 | 157 |
| Eli Lilly & Co. | 14 | 13 | 173 |
| F. Hoffmann-La Roche AG | 8 | 4 | 22 |
| Amgen Inc. | 4 | 4 | 36 |
| Boehringer Ingelheim International GmbH | 3 | 1 | 7 |
| Kailera Therapeutics Inc. | 3 | 3 | 33 |
| Metsera Inc. | 2 | 2 | 23 |
The obesity outsourcing market is primarily a large-pharma execution market. The key commercial opportunity is not basic protocol support, but scalable multi-country CTIS operations plus specialist vendor orchestration for measurement-heavy obesity programs.
Across 247 CTIS country-decision entries, the median Part II processing time is 38 days. CRO-supported entries have a median of 37 days across 219 country entries, while non-CRO entries have a median of 72.5 days across 28 entries. Germany has 35 country entries, Poland 26, Spain 25, Denmark 20, and the Netherlands 18.
For obesity sponsors, CTIS/EU submission support is most valuable when a trial spans many national Part II packages. The most CRO-intensive countries are also the highest site-volume markets, so regulatory operations and site activation should be treated as one connected delivery problem.
The same CTIS variables also answer which phases, years, and sites are most operationally relevant for CRO targeting.
The practical CRO opportunity is Phase III obesity execution, especially in Germany, Poland, Spain, Italy, Czechia, and the Netherlands. The best targeting signal is not only sponsor name, but the combination of CTIS country spread, site count, participant burden, and outsourced measurement infrastructure.