EARLY - PHASE CLINICAL RESEARCH

In-House PK / PD

Clinical Trials

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

CRS conducts in-house Pharmacokinetic and Pharmacodynamic (PK/PD) studies within its dedicated early-phase clinical research unit, enabling detailed characterization of a drug’s behavior and biological effects in humans. Our unit is designed to support intensive sampling, frequent assessments, and complex study designs required to generate high-quality PK and PD data.

We support a broad range of PK/PD studies in healthy volunteers and selected patient populations, including dose-proportionality, food-effect, drug–drug interaction, and mechanism-of-action assessments. Protocol execution focuses on precise timing of sample collection, standardized procedures, and controlled study conditions to minimize variability and ensure data reliability.

CRS manages all clinical aspects of in-house PK/PD studies, from subject recruitment and screening through dosing, inpatient and outpatient visits, and specialized assessments. Our teams are experienced in managing dense PK sampling schedules alongside PD endpoints such as biomarkers, physiological measurements, and functional assessments, ensuring accurate linkage between exposure and effect.

PK/PD activities are closely coordinated with bioanalytical, data management, and statistical functions to support timely data availability and integrated analysis. Continuous medical oversight and real-time review of emerging results allow for informed operational decisions during study conduct.

By combining dedicated infrastructure, experienced early-phase teams, and integrated clinical services, CRS delivers PK/PD studies that provide meaningful insight into drug behavior and support informed dose selection and development strategy.

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