Deliverables
Localized document trackers, submission-ready packages, study contract and budget negotiation follow-up logs, approval trackers, and activation checklists.
Start-up services
- Country and site feasibility assessments
- Investigator identification and site selection support
- Site qualification visits and start-up gap assessment
- Study contract and budget negotiations
- Document collection, review, and completeness tracking
- Coordination of local submission packages
- Start-up milestone tracking and activation risk follow-up
Czech submission coordination
- SÚKL-facing clinical trial submission support where applicable
- Ethics committee documentation and communication support
- Patient-facing document review for local consistency
- Timeline planning aligned with EU CTR and site-level dependencies
- Transition planning from start-up into monitoring activity
Operational benefit
One senior point of contact for site readiness, local documentation quality, and escalation management during start-up.
Connected services
Start-up can be connected with CRA monitoring and CTIS submission support for a cleaner handover into active study conduct.
Related support
Study contract and budget negotiation support
Ethics committee submission support
After start-up
Clinical trial monitoring in Czech Republic
CTIS support for EU clinical trials
Prepare Czech site activation.
Use the contact form to share your study synopsis, target timelines, indication, and preferred Czech regions or sites.