Complex protocols
Combination programs often need tighter coordination between study operations, patient-facing documents, and product-specific records.
Cross-functional support
Monitoring, ethics, start-up, and regulatory tasks need to stay aligned rather than being handled in isolation.
Relevant experience
Support includes experience with drug-device combinations and five drug-IVD/CDx combinations.
Support can include
- Study start-up planning for mixed-product programs
- Review of ethics submission packages and patient-facing materials
- Monitoring support for protocol compliance and site documentation
- Operational coordination across sponsor, CRO, and site stakeholders
- Practical local follow-up during submission and study conduct
Where support adds value
- Programs where drug and device components create extra documentation complexity
- Studies that need ethics, monitoring, and start-up work kept tightly aligned
- Projects where Czech country input must fit a broader international program
- Teams that want one experienced local contact for mixed-product study operations
Related pages
Medical device clinical trials in Czech Republic
Regulatory affairs in Czechia
More support
Ethics committee submission support
Clinical trial monitoring in Czech Republic
Discuss a combination study in Czechia.
Use the contact form to describe the product mix, study phase, planned Czech sites, and the support needed for start-up, ethics, or monitoring.