Clinical Research Background

European Early-PhaseClinical TrialsTrusted 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.

Celebrating 20 years
EARLY-PHASE CLINICAL RESEARCH

Celebrating 20 years of successful work in the field of clinical research.

Our Expertise

Comprehensive Clinical Services

From first-in-human studies to bioequivalence trials, we deliver precision clinical research with European regulatory excellence.

Phase I-IV Clinical Studies

First-in-human safety and tolerability assessments with comprehensive pharmacokinetic profiling in healthy volunteers.

Single & Multiple Ascending Dose
Safety Monitoring
PK Sampling
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Bioequivalence Studies

Comparative bioavailability studies demonstrating therapeutic equivalence for generic drug development and registration.

Crossover Designs
Fed/Fasted Studies
Regulatory Submission
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Bioavailability Studies

Absolute and relative bioavailability assessments to characterize drug absorption and systemic exposure.

Formulation Comparison
Route of Administration
Food Effect Studies
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PK/PD Studies

Integrated pharmacokinetic and pharmacodynamic evaluations to establish dose-response relationships.

Exposure-Response Analysis
Biomarker Assessment
Modeling Support
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Clinical Monitoring

Ensuring study compliance, data integrity, and patient safety through expert on-site and remote monitoring.

Site Selection & Feasibility
Risk-Based Monitoring
GCP Compliance Oversight
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Data Management & Statistics

Fully validated electronic data capture systems with in-house servers ensuring high security and quality data monitoring.

FDA-Approved EDC with Full Audit Trail
GXP-Compliant Validation
Expert Statistical Analysis
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Regulatory Services &Study Startup

We provide comprehensive support for protocol development, ethics and authority submissions, and regulatory interactions in the EU. We ensure fast and efficient study start-up with rapid recruitment strategy and our fast-pace CTIS submission options.

Protocol Development

Expert support for comprehensive protocol development aligned with EU regulations.

Ethics & Authority Submissions

Complete management of ethics committee and regulatory authority submissions.

Fast-Track CTIS Submissions

Leverage our fast-pace CTIS submission options for accelerated approval timelines.

Rapid Recruitment Strategy

Efficient study start-up with proven recruitment strategies and established volunteer database.

Global Sponsors

Trusted by leading pharmaceutical organizations worldwide

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Risk-Based Approach toClinical Studies

Quality Assurance oversight of operations is risk-based and provides pro-active risk mitigation, as well as continuous process optimization as we collect data from our ongoing studies. Each deviation is carefully examined and documented with progressive technology made with purpose. Our processes have been tested, approved and inspectioned by Health Ministry of RS and audited with various sponsors.

Pro-active Risk Mitigation

Continuous monitoring and early intervention strategies

Process Optimization

Data-driven continuous improvement methodology

Regulatory Approved

Tested and inspected by Health Ministry of RS

Background
2005
Established
20+
Years of Experience
50+
Collaborations with Sponsors
72
Participant Capacity on Site
About CRS

Slovenia's LeadingPhase I Clinical Partner

CRS is a Slovenian CRO and the only regional Phase I clinic in Slovenia. Our National Agency allows us to fast-track CTIS approval for studies, giving sponsors a competitive advantage in EU regulatory pathways.

Our well-connected network of doctors, scientists, biostatisticians, and data management experts provides the highest level of complex scientific and logistical support. We work closely with University Medical Centre and University of Ljubljana to answer your most complex questions.

We aim to be a trusted one-stop destination delivering end-to-end services throughout the product lifecycle—fast and efficient, without compromising on quality and patient safety.

Lake Bled, Slovenia
Our Journey

28 Years of Clinical Excellence

2005Company Founded

CRS Clinical Research Services established its first clinical operations, beginning our journey in early-phase research.

2005Service Expansion

Launched Phase II-IV Monitoring & Clinical Services, broadening our capabilities in clinical research.

2010Facility Growth

Expanded our premises to accommodate growing demand and enhance participant comfort.

2017Phase I Unit Launch

Established our Phase I Unit - the only in-house clinical unit in Slovenia.

2020Industry Leadership

Became the leading Phase I clinic with successful completion of 3-4 complex PK/PD studies with 70+ participants each.

2023Team Expansion

Opened another facility for staff, just 3 minutes from the clinic, supporting our growing team.

2024Global Presence

Attended CPHI, strengthening our international partnerships. Now celebrating 50+ successful collaborations and 20 years of excellence.

2026Future Vision

Planning to attend Bio-Europe, continuing our commitment to innovation and global collaboration in clinical research.

Our Team

Expert Leadership & Specialists

Our multidisciplinary team brings together decades of combined experience in clinical research, regulatory affairs, and medical expertise.

Core Team

Tanja Turk, M.Pharm

Clinical Research Scientist, CEO & Founder of CRS d.o.o.

Aleksander Turk

Data Manager, Lead Engineering Scientist. Specialist for OpenClinica

Evelina Turk, M. Pharm

Administrative & Submissions Specialist

Filip Turk

Study Coordinator and Recruitment Specialist

Medical Experts

Dr. Matjaž Fležar

Respiratory Diseases - Golnik Medical Treatment Center

Dr. Tajda Košir Božič

Renowned Gastroenterologist

Dr. Andrej Kravos

Main Practitioner

Background
Evelina Turk
"

Slovenia is an attractive destination for our clients, as it offers rapid, cost-effective and high-quality clinical development solutions.

Evelina Turk, M. Pharm
Business Development Manager
evelina.turk@crs.si

Extended Network

Our extended team comprises Medical Monitors, Biostatisticians, and experts from the Faculty of Pharmacy, along with many other specialized professionals who support our clinical research operations.

Why Choose CRS

Strategic Advantages

Located in the heart of Europe, we combine operational excellence with comprehensive clinical capabilities.

Strategic European Location

Ljubljana, Slovenia
Direct access to EU patients & regulations
Modern Facility
Purpose-built clinical unit
Expert Team
University partnerships & specialists

Core Capabilities

70+ Inpatient Beds
For controlled studies
24/7 Medical Care
Continuous monitoring
Recruitment Power
Large volunteer database
Our Capabilities

World-Class Infrastructure

Our state-of-the-art facilities and experienced team ensure the highest standards of clinical research excellence.

Awards, Certifications & Quality Standards

Leading the way with internationally recognized excellence

GCP Compliant

Full ICH-GCP compliance certification

GDP Certified

Certified Good Distribution Practices

Ministry of Health Licensed

Official RS regulatory approval

3x Best CRO Nominee

Industry excellence recognition

Contact Us

Let's Discuss YourClinical Needs

Ready to advance your clinical development program? Our team of experts is here to help you design and execute successful Phase I studies.

Download Our Brochure
Location:Ukmarjeva ulica 6, 1000 Ljubljana, Slovenia
Business Hours:Monday - Friday: 8:00 - 17:00 CET

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