Across 56 unique CTIS-listed Alzheimer’s and dementia-related Phase II/III trials in Europe, 36 trials included at least one CRO or operational support provider, a CRO-use rate of 64.3%. IQVIA was the most active listed provider, appearing in 21 of 56 trials, followed by Signant Health in 13 and PPD / Pharmaceutical Product Development in 9. CRO demand was strongest in operationally large trials: 19 of 19 trials with 21+ sites, 9 of 9 trials with 7+ countries, and 10 of 10 trials with 501+ planned participants used CRO support.
IQVIA was the clear leader, appearing in 21 of 56 trials (37.5%). Signant Health followed with 13 trials (23.2%), while PPD / Pharmaceutical Product Development and Medidata Solutions each appeared in 9 trials (16.1%). These counts reflect CTIS-listed CRO or operational-support organizations, including full-service CROs, eCOA/scales vendors, central lab providers, imaging vendors, and eClinical platforms.
Alzheimer’s CTIS dossiers rely less on a single full-service CRO model and more on layered outsourcing: full-service or regional CROs plus specialist providers for cognitive scales, eCOA, biomarkers, imaging, and eClinical systems.
CRO use increased sharply with trial scale. Only 2 of 19 trials with 1–5 sites used CROs (10.5%), compared with 19 of 19 trials with 21+ sites (100.0%). The same pattern appeared by geography and enrollment: 9 of 9 trials with 7+ CTIS countries and 10 of 10 trials with 501+ planned participants used CRO support.
The practical CRO trigger is not Alzheimer’s as a disease alone, but CTIS operating complexity: once the study becomes multi-country, high-site, or high-enrollment, outsourcing becomes almost universal.
CRO use was highest in Alzheimer’s disease psychosis and agitation studies: 8 of 8 psychosis trials and 6 of 6 agitation trials used CRO support. Early/prodromal Alzheimer’s disease also showed high outsourcing intensity, with 10 of 12 trials (83.3%) CRO-supported and the largest site footprint at 412 listed sites.
| Indication subgroup | CRO use | Sites |
|---|---|---|
| Alzheimer’s disease psychosis | 8 / 8 · 100.0% | 276 |
| Agitation in Alzheimer’s dementia | 6 / 6 · 100.0% | 257 |
| Early / prodromal Alzheimer’s disease | 10 / 12 · 83.3% | 412 |
| Inherited / genetic Alzheimer’s disease | 2 / 3 · 66.7% | 21 |
| Other dementia / adjacent dementia | 3 / 5 · 60.0% | 48 |
| Alzheimer’s disease / dementia, broad | 7 / 19 · 36.8% | 162 |
Behavioral and neuropsychiatric Alzheimer’s trials appear especially outsourcing-heavy, likely because they combine caregiver workflows, site training, cognitive/behavioral assessment consistency, and multi-country CTIS localization.
The most frequent outsourced functions were central lab, biomarker, PK, and sample testing, present in 33 of 56 trials (58.9%). eCOA, cognitive scales, and rater training appeared in 30 trials (53.6%), followed by imaging, ECG, and cardiac safety in 27 trials (48.2%). Site operations, monitoring, project management, and CTIS/ethics support appeared in 25 trials (44.6%).
The top outsourced functions map directly to Alzheimer’s operational pain points: biomarker confirmation, cognitive outcome consistency, imaging/ECG safety oversight, and country-specific CTIS Part II implementation.
Spain was the largest CTIS geography by trial footprint, appearing in 33 trials with 188 listed sites and 1,742 country-level participants. France followed with 25 trials and 169 sites, while Italy, Poland, Germany, and Czechia formed the next major operational cluster. Across 211 country-level CTIS processing records, the median processing time was 116 days.
| Country | Trials | Sites | Participants |
|---|---|---|---|
| Spain | 33 | 188 | 1,742 |
| France | 25 | 169 | 807 |
| Italy | 24 | 141 | 810 |
| Poland | 19 | 133 | 929 |
| Germany | 15 | 121 | 501 |
| Czechia | 16 | 80 | 461 |
For Alzheimer’s sponsors planning EU submissions, Spain, France, Italy, Poland, Germany, and Czechia are the main operational countries to prioritize for CTIS Part II readiness, site activation, translated ICFs, caregiver/LAR documents, and recruitment materials.
The same CTIS fields also answer sponsor-type, recruitment, consent, and phase-complexity questions. Pharma or industry sponsors used CROs in 33 of 38 trials (86.8%), compared with 3 of 18 academic, hospital, or research-sponsored trials (16.7%). Digital or remote recruitment appeared in 20 of 56 trials (35.7%), while caregiver or study-partner consent workflows appeared in 40 of 56 trials (71.4%).
The highest-value adjacent use case is CTIS submission planning: Alzheimer’s trials frequently require country-specific caregiver, study-partner, LAR, assent, and recruitment materials, making document localization and Part II coordination a major CRO opportunity.
CRO/support organization: any CTIS-listed CRO or third-party operational provider identified in the CRO field, including full-service CROs and specialist vendors.
CTIS: Clinical Trials Information System, the EU portal used for clinical trial application and country-level authorization workflows.
eCOA: electronic clinical outcome assessment; EDC: electronic data capture; IVRS/IWRS: systems for randomization, treatment assignment, and supply workflows.