Partnering for CROs
We deliver countries for CROs. 63 studies delivered as the local operating partner inside the global programmes of mid-size and large CROs — regulatory, start-up, monitoring and site management. Each of them qualified us as a vendor before contracting.
Who this is for
Large and mid-size CROs that need a trusted local operating partner in countries outside their direct footprint.
How we engage
- Sub-CRO and local operating partner
- FSP — CRAs, regulatory, CTAs
- Site management and monitoring only
Typical work
Country operations for global trials, regulatory submissions.
What a partner is actually buying
Our own people in fourteen countries
Our own CRAs and regulatory specialists, not subcontractors — eight EU member states, alongside our six delivery countries.
One CTIS submission across eight EU member states
Poland, Czechia, Slovakia, Romania, Croatia, Latvia, Lithuania and Spain all sit under the EU Clinical Trials Regulation: one CTIS submission, with our own regulatory specialists handling each country's national part in the local language, and our own CRAs monitoring at site.
Start-up in parallel, not in sequence
Our last multi-country programme went from core pack to first patient in five countries in four months.
Enrolment that holds up
Across two independently compiled datasets, four out of five screened patients were randomised.
The menu
- Regulatory and ethics submissions
- Study start-up
- Monitoring and source data verification
- Project management
- Medical monitoring
- Safety submissions and medical review
- Quality assurance and inspection readiness
- Certified translation
- Clinical logistics and import licences
Vendor qualification
Available on request before contracting: QMS documentation, insurance, CVs, SOP index and audit history.