CLINICAL SERVICES

Site

Selection

Based in the European Union, fully GCP compliant, with a dedicated Phase I unit of up to 72+ participants.

Effective site selection is critical to study feasibility, recruitment success, and on-time execution. CRS provides structured, data-driven site selection support to ensure that clinical trials are placed at sites with the appropriate experience, infrastructure, and patient access to meet protocol requirements.

We assess potential sites based on therapeutic experience, operational capacity, staffing availability, facility suitability, and historical performance. Our evaluation includes feasibility questionnaires, investigator interviews, and review of prior study metrics to confirm realistic enrollment projections and operational readiness. Particular attention is given to protocol complexity, dosing requirements, safety oversight, and visit schedules, especially for early-phase and first-in-human studies.

CRS supports sponsors throughout the full site selection process, from initial long-list development to final site confirmation. We coordinate site outreach, manage feasibility data collection, and provide comparative analyses to support informed decision-making. Our team ensures that selected sites align with regulatory expectations, ethics requirements, and study timelines.

Once sites are selected, we facilitate a smooth transition into study start-up by supporting contract and budget discussions, investigator documentation collection, and site readiness activities. Close collaboration with sponsors and investigators ensures alignment on expectations, timelines, and responsibilities from the outset.

By applying a pragmatic and experience-based approach, CRS helps minimize start-up delays, reduce recruitment risk, and establish a strong operational foundation for successful clinical trial execution.

Request For Proposal
  • Ethics Committee approval for all studies
  • Regulatory strategy and regulatory submissions
  • Study start-up and site activation
  • Clinical trial planning and study design
  • Clear participant information and informed consent
  • Conducted in compliance with ICH-GCP and EU regulations
  • 24/7 safety monitoring and emergency readiness
  • Qualified investigators and trained study teams
  • Confidential handling of participant data

20+ Years

Of Experience in Early-Phase Clinical Research

Phase I Unit

Infrastructure organized across two dedicated units for controlled inpatient studies

EU Certified CRO

Slovenia, European Union regulatory environment

GCP Compliant

Conduct under international quality standards