Early-phase clinical research

European Early-Phase Clinical Trials.

Trusted Partner for 20 Years.

We are an European Clinical Research Organization specializing in early-phase studies in healthy volunteers, including first-in-human, SAD/MAD, PK/PD, and bioequivalence studies.

Based in the European Union, fully GCP compliant, with a dedicated Phase I unit of up to 40 participants.

20+ Years

Experience in early-phase clinical research

Phase I Unit

Up to 40+ inpatient beds for controlled and safe studies.

EU Based

Slovenia, European Union regulatory environment

GCP Compliant

Conduct under international quality standards

Our Early-Phase Services

Our Early-Phase Services CRS provides a complete range of early-phase clinical services, from first-in-human study design to bioequivalence, PK/PD, and clinical pharmacology programs.

Phase I Clinical Trials

Design and conduct of first-in-human, single and multiple dose studies in healthy volunteers or selected patient populations.

First-in-Human (FIH)

Safety-driven first-in-human trials with intensive medical monitoring and real-time data review for early decision making.

SAD/MAD Dose Escalation

Structured single and multiple ascending dose studies to characterize safety, tolerability, and pharmacokinetics.

BA/BE Studies

Bioavailability and bioequivalence trials for generics, reformulations, and fixed-dose combinations in line with EMA guidance.

PK/PD Studies

Pharmacokinetic and pharmacodynamic investigations with intensive sampling, controlled conditions, and expert analysis.

Bridging & Phase I–IIa Designs

Hybrid early-phase designs to accelerate proof-of-concept and support regulatory and development decisions.

Regulatory & Study Startup

Support for protocol development, ethics and authority submissions, and regulatory interactions in the EU.

Data Management & Statistics

Structured data capture, cleaning, and biostatistical analysis leading to clear, regulatory-ready clinical study reports.

Planning a Phase I, BA/BE, or PK/PD study in Europe?

About Us

We are an established European clinical research organization headquartered in Slovenia, focused on early-phase clinical studies in healthy volunteers. For more than 20 years we have supported pharmaceutical companies, biotechnology innovators, and CRO partners in generating high-quality clinical pharmacology data.Our dedicated Phase I unit, experienced medical team, and streamlined regulatory pathways allow us to deliver safe, efficient, and scientifically robust studies for sponsors worldwide.

  • Specialized in Phase I and early-phase clinical trials
  • Modern inpatient facility with up to 40 beds
  • International sponsors from Europe, the United States, and beyond
  • Full compliance with EU and national regulations

Central European location

CRS operates from Slovenia, a member state of the European Union, with convenient access to patients and healthy volunteers, and efficient connections to major European and global hubs.Our location offers an attractive environment for sponsors seeking cost-effective, high-quality early-phase research in the EU.

Why Sponsors Choose CRS

CRS combines the experience of a long-established research center with the agility and personal attention of a focused early-phase partner.

  • 20+ years of experience in Phase I and early-phase clinical development.
  • Sponsors from 15+ countries.
  • Flexible and cost-effective collaboration tailored to small and mid-size biotech and pharma companies.
  • Established volunteer database and efficient recruitment processes ensure timely study execution.
  • Dedicated Phase I unit with up to 40+ inpatient beds for controlled and safe studies.

Experience at a glance

1996s
CRS d.o.o. established as a clinical research center in Slovenia.
20+ years
Continuous clinical research operations with focus on early-phase trials.
GCP-compliant processes
GCP-compliant processes and quality oversight aligned with EMA and national regulations.
Efficient EU regulatory pathways
Efficient EU regulatory pathways and streamlined startup for international sponsors.

For study participants

Participate in Clinical Studies

CRS regularly conducts supervised clinical studies that contribute to the development of new medicines. Volunteers receive medical examinations and appropriate compensation in a safe, controlled environment.

  • Medical supervision by experienced clinical staff
  • Ethics committee approval for all studies
  • Clear information and informed consent
  • Financial compensation for participation
Become a volunteer Download Brochure