Local insight, EU discipline.
Prague-based clinical research support aligned with ICH-GCP, EU CTR, MDR, ISO 14155, and Czech submission expectations.
19+Years in clinical research
Pharma + MDPharmaceutical, medical device, and combination studies
Start-Up to Close-OutMonitoring, CTIS, ethics, and regulatory coordination
PragueCzech Republic coverage with additional support in Slovakia
Boutique clinical operations
Focused support for sponsors entering Czechia.
ClinicalResearchCZ helps sponsors and CRO teams translate protocol requirements into practical site workflows, submission packages, and monitoring activity in the Czech Republic. The work is designed for lean communication, clear documentation, and inspection-ready conduct.
Support can begin during feasibility and study start-up, continue through monitoring and issue follow-up, and extend into CTIS coordination, ethics committee communication, and regulatory lifecycle tasks.
Who this is for
Built for teams that need experienced support quickly.
- Sponsors that need local Czech Republic execution without adding another handover layer
- CRO teams that need temporary senior support for monitoring, start-up, or submissions
- Biotech companies entering Czechia for the first time
- Medical device and combination-program teams needing practical local coordination
Typical requests
Why clients usually get in touch.
- A study needs freelance CRA coverage for Czech sites on short notice
- Site activation is delayed by missing documents, contracts, or budget follow-up
- A submission package needs Czech country input or ethics coordination
- A sponsor wants one senior contact across monitoring, start-up, and local regulatory tasks
Core services
From site selection to compliant trial conduct.
Each service is structured to reduce handover friction and keep operational, regulatory, and site-facing work connected.
CRA monitoring
Site qualification, initiation, interim monitoring, close-out visits, SDV/SDR, protocol compliance checks, issue escalation, and documentation review.
View monitoring servicesStudy start-up Czechia
Country feasibility, site identification, submission package coordination, tracker maintenance, and activation risk follow-up.
View start-up servicesRegulatory and CTIS
Clinical trial application planning, Part I and Part II CTIS support, RFI coordination, ethics submissions, and Czech authority communication.
View CTIS supportCzech Republic trial focus
- Clinical trial monitoring in Prague and across Czechia
- Pharmaceutical and medical device study support
- Combination programs, including drug-device and diagnostic-linked studies
- Broad therapeutic area exposure built over 19+ years in clinical research
- Investigator site communication and practical site readiness checks
- Coordination with sponsor, CRO, vendor, and site stakeholders
Regulatory alignment
- ICH-GCP and EU Clinical Trials Regulation workflows
- SÚKL-facing clinical trial submission coordination
- Ethics committee documentation and patient-facing material review
- MDR and ISO 14155 considerations for medical device studies
- Direct regional support from Prague, with additional Slovakia coordination where needed
Commercial support pages
High-intent support where projects usually slow down.
These pages focus on the work that often drives urgent inquiries: monitoring coverage and start-up negotiations.
Clinical trial monitoring in the Czech Republic
For sponsors and CROs that need freelance CRA support, interim monitoring coverage, co-monitoring, or site follow-up in Czechia.
View monitoring support pageStudy contract and budget negotiation support
For projects where site activation depends on contract turnaround, budget alignment, and practical coordination with Czech study sites.
View negotiation support pageNext step
Plan clinical trial support in the Czech Republic.
Use the contact form to share the study phase, indication, target countries, planned timelines, and the type of support needed. Typical inquiries include freelance CRA support, study start-up, ethics submissions, CTIS coordination, and Czech site coverage.