Clinical Trials
FELS Medical
Clinical Trials in Serbia
At FELS Medical, we know that clinical development is the decisive step where innovation proves its value in real-world care. We guide and support our partners through this critical transition, ensuring that studies are designed, executed, and reported with the same rigor and precision that defines our preclinical work. We provide support across the entire spectrum of clinical trials — from first-in-human (FIH) applications and feasibility studies to pivotal and post-market trials. Each phase demands a unique balance: scientific depth to satisfy regulators, clinical simplicity to protect patients, and operational agility to keep timelines moving.
Why FELS in Serbia?
One of our core strengths is the ability to conduct cardiovascular clinical trials in Serbia, leveraging a strong medical tradition, experienced investigators, and highly motivated clinical teams. With FELS Medical’s scientific oversight and operational leadership, sponsors benefit from:
- Faster approvals and flexible timelinescompared to many EU countries.
- Access to highly skilled cardiovascular centers with investigators experienced across all study phases.
- Cost-effective execution without compromising on quality or patient safety.
- EU-aligned regulatory standards: while Serbia is not an EU member, its clinical trial framework is harmonized with European MDR requirements. Data generated in Serbia is fully acceptable for CE-mark submissions.
Belgrade: The Heart of Our Operations
Belgrade, the capital of Serbia with a population of 1.8 million, is the hub of our clinical operations. Within a 10 km radius, the city hosts three major cardiac centers, with a fourth only 45 minutes away. These centers perform annually:
>3,000 open-heart surgeries
~2,000 coronary angioplasties
~10,000 coronarographies
~600 TAVR procedures
~1,000 rhythmology procedures (e.g. ablations, device implants)
This volume translates into unmatched patient access and clinical expertise. Combined with FELS Medical’s hands-on project management, we ensure rapid recruitment, high-quality data, and seamless trial execution.
Accessibility & Infrastructure
Easy international access: Belgrade Airport connects the city with 100+ destinations across US, Europe, the Middle East and beyond, including multiple daily flights to New York, Vienna, Zurich, Frankfurt, Munich, Amsterdam, Paris, Istanbul and Beijing.
Accommodation & logistics
Belgrade offers all major international hotel chains — Marriott, InterContinental, Hyatt, and more — making it easy for sponsors, monitors, and investigators to stay connected and comfortable.
FELS and Regulatory Alignment
Clinical data is the cornerstone of every MDR and CE-mark application. With FELS Medical, sponsors can rely on trials that are ethically sound, scientifically rigorous, and seamlessly aligned with regulatory expectations:
- Protocols that satisfy both clinical investigators and reviewers.
- Trial designs that generate robust safety and performance data for MDR submissions.
- Documentation that integrates directly into technical files and Clinical Evaluation Reports (CERs).
In short:
FELS Medical combines scientific oversight, regulatory expertise, and strong local presence to make Serbia — and especially Belgrade — the ideal environment for cardiovascular trials. From first-in-human to post-market studies, we accelerate your pathway to CE-mark and MDR success.
FELS CLINICAL RESEARCH LLC BELGRADE
Milutina Milankovica 7dj
11070 Belgrade
Serbia
