EARLY - PHASE CLINICAL RESEARCH

In-House Phase I

Clinical Trials

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

CRS conducts In-house Phase I Clinical Trials within its dedicated early-phase clinical research unit, providing sponsors with full control, close medical oversight, and integrated operational execution. Our facility is specifically designed to support first-in-human and complex early-phase studies in a controlled and compliant clinical environment.

We specialize in the conduct of FIH, SAD, MAD, food-effect, bioavailability, bioequivalence, and other early-phase designs in healthy volunteers and selected patient populations. Studies are performed under continuous medical supervision with immediate access to trained investigators, nursing staff, and emergency support. This structure enables rapid response to safety findings and efficient execution of protocol-driven activities.

CRS manages all aspects of In-house Phase I trial conduct, including subject recruitment, screening, dosing, inpatient and outpatient visits, pharmacokinetic sampling, and safety monitoring. Our unit is equipped to handle intensive PK schedules, overnight confinement, and complex dosing regimens, ensuring accurate data collection and protocol compliance.

Clinical operations are fully integrated with pharmacovigilance, regulatory affairs, data management, and project management functions. This allows seamless coordination of safety reporting, dose escalation decisions, and study amendments, while maintaining full regulatory compliance and data integrity.

By combining dedicated infrastructure, experienced early-phase staff, and integrated CRO services, CRS delivers Phase I clinical trials that prioritize subject safety, operational reliability, and high-quality clinical data to support confident development decisions.
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