20+ Years

Of Experience in Early-Phase Clinical Research

Phase I Unit

Infrastructure organized across two dedicated units for controlled inpatient studies

EU Based CRO

Based in Slovenia, operating within the EU regulatory framework

ICH-GCP Standards

Conduct under International Quality Standards

Our Clinical Research Services

Comprehensive CRO services enabling efficient and compliant clinical trials with dedicated regional support.

<subject>[background image] image of robotics lab (for a robotics and automation)</subject>
Regulatory &study startup

Accelerate Trial Activation

Parallel regulatory and ethics submissions accelerate study start-up across EU frameworks by coordinating CTA preparation, ethics committee approvals, and regulatory interactions simultaneously while maintaining strict compliance with EMA and national authority requirements.

Regulatory & Study Startup

CTA, ethics submissions and coordinated study activation.

Feasibility

Identification and evaluation of qualified study sites.

Site Selection

Selection and qualification of appropriate clinical study sites.

Pharmacovigilance

Safety monitoring and regulatory safety reporting.

Regulatory Affairs

Regulatory submissions and lifecycle compliance support.

Project Managament

Central coordination of study execution and timelines.

Clinical Monitoring

Risk-based monitoring for safety and data integrity.

Quality Assurance

Audits, compliance oversight, and inspection readiness.

Data management & statistics

Integrated Data Management and Statistical services.

Therapeutic Areas

Our CRS Team has accumulated extensive expertise across a broad spectrum of therapeutic areas, conducting studies in all phases and delivering results for sponsors worldwide.

Asthma & COPD

Respiratory diseases

Neurology

Parkinson's disease, MSA, PSP

Alzheimer's Disease

Neurodegenerative research

Chelation Studies

Metal chelation therapy

Haematology

Sickle Cell Disease, Thalassemia

Diabetes Type I

Endocrinology & metabolic

Oncology

Breast cancer, Prostate cancer

Gastroenterology

GERD & GI disorders

Metabolic & Infectious Diseases

Including HIV

Pediatric Studies

Phenylketonuria & rare pediatric conditions

Ophthalmology

TED, Graves disease

Cannabinoids

Epilepsy studies

Early-Phase Clinical Trials

Supporting efficient and compliant early-phase clinical trials with experienced clinical teams.

Regulatory & study startup

Early Phase Pilot Studies

We provide focused early-phase clinical services for studies conducted in healthy volunteers, aligned with European regulatory requirements. Our experienced clinical teams support pilot and pharmacokinetic studies with comprehensive safety monitoring, efficient study conduct, and high-quality data generation for early development decisions.

<subject>[background image] image of robotics lab (for a robotics and automation)</subject>

First-in-human trials

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

Phase I Clinical Trials

Early-phase clinical studies in healthy volunteers, including single and multiple ascending dose designs.

Bioavailability & bioequivalence

EMA-guided studies for generics, reformulations, and fixed-dose combinations.

BA/BE Studies

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

PK/PD Studies

Pharmacokinetic and pilot studies supporting early decision-making and development planning.

Bridging & Phase I–IIa Designs

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

Regulatory-ready clinical reports

Validated data capture, cleaning, and biostatistical analysis for compliance

ABOUT US

CRS – Your Regional Clinical Research Partner

“CRS is a regionally operating, mid-sized, full-service CRO aiming to improve access to new therapies for the patients in need.”

Founded in 2005 as a family-owned company, CRS brings over 20 years of experience and a stable, reliable management team that sponsors can count on. Our continuity and long-term partnerships set us apart as a trusted partner in clinical development.

Our quick project start-up and rapid preparation of regulatory package documentation are among our most highly recognised features — highly appreciated by our clients and instrumental in keeping development timelines on track.

CRS is a 100% privately owned 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 CRS Team has many years of experience across all study phases and a wide range of therapeutic areas. We work closely with University Medical Centre and University of Ljubljana to provide the highest level of scientific and logistical support.

our FAcilities

Phase I Clinical Unit

Our Location

CRS operates a dedicated Phase I clinical unit in the European Union, configured to support controlled inpatient studies in healthy volunteers. The unit is designed for early-phase clinical research conducted in sequential cohorts, with operational layouts appropriate for safety monitoring and protocol-driven study conduct.
Our Phase I infrastructure is organized across two coordinated units, allowing flexible study planning while maintaining a controlled clinical environment. The facilities support inpatient study conduct, subject observation, dosing activities, and on-site clinical operations aligned with early-phase requirements.All study activities are supported by experienced clinical staff and established operational procedures appropriate for early-phase clinical research within the EU regulatory context.

Our staff

Our Staff and collaborators are professionals with many years of experience. Our two clinical trial facilities include adaptive clinical pharmacology units for Phase I and II studies in healthy normal volunteers (HNV) and patient populations for small and large molecules. For long or short stays, our units have a team of experts to conduct trials in a range of therapeutic areas. With dedicated in-house pharmacy, we are the single-source solution to your small and large moleculeearly-phase clinical trial needs.

Recruitment

Our advanced level of clinical expertise enables us to successfully recruit and conduct clinical trials involving a broad range of healthy normal, special, and patient populations. Leveraging a combination of our existing database and proactive participant outreach strategies, we can help you get ahead in a wide range of study types, methods of administration, and therapeutic areas.

Our Capability

- 72+ bed dedicated early-phase unit.
- Experienced investigators and continuous medical oversightIn-house
- Pharmacy and IMP handling
- Intensive PK sampling and processing
- Hospital access and emergency coverage
- EU & EMA-aligned regulatory compliance





our TEAM

Trusted by Regulated Institutions

Organizations rely on our standards regulated solutions for compliance and product data accuracy.

“20+ years of experience in Phase I-IV clinical development”

Tanja Turk
CEO General Manager
image of diverse business team working (for an erp company)

“Enabling the future Development of Clinical Research.”

Evelina Turk
Business Development

“Data resolution consistentcy and compliance requirements.”

Alesander Turk
Senior Data Manager

“Standards-aligned infrastructure for Clinical Research data.”

Filip Turk
Operations Lead
For study participants

Participate In Clinical
Trials

Healthy Volunteer Studies

CRS conducts early-phase clinical studies in healthy volunteers as part of Phase I clinical development programs. Studies are designed and conducted in accordance with applicable ethical standards and regulatory requirements within the European Union.

Volunteer recruitment & management

An established volunteer pool and structured screening processes support efficient participant identification and study enrollment. All volunteers are evaluated according to protocol-specific inclusion and exclusion criteria prior to study participation.Study participationHealthy volunteer participation is coordinated and supervised by qualified medical staff, with study activities conducted in a controlled inpatient environment appropriate for early-phase clinical research.

Study participation

Healthy volunteer participation is coordinated and supervised by qualified medical staff, with study activities conducted in a controlled inpatient environment appropriate for early-phase clinical research.

Become a Volunteer
Contact

Contact Us

Submit your request or general information.

© 2026 CRS d.o.o. All right reserved.