Countries of Operation: Serbia

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Serbia - a land of opportunity for clinical research

Over the years, Serbia has become a highly reputable location to conduct clinical research. The country has actively strived towards developing a robust healthcare system and has adopted full GCP compliance. An increasing number of biotechnology and pharmaceutical companies are now willing to envision Serbia as a potential regional hub for their business operations and thus are making significant investments in the Serbian market.


Serbia Quick Facts
per 1 000 population
hospital beds
per 1 000 population
Total population
initiated clinical trials
in 2022
Life expectancy
Main advantages of conducting clinical trials in Serbia:
  • High recruitment rates and significant patient population
  • Enhanced regulatory framework and validated safety guidelines under Serbian law and the Medical Devices Agency’s
  • Moderate research costs and investigator fees
  • High standards of clinical research
  • High-quality, accredited research centers specializing in clinical trials
  • Well-qualified, compliant, experienced, and GCP-certified investigators and study teams
  • An increasing and ever-improving business infrastructure for clinical trials, including medicines and medical devices
  • An opportunity to participate in clinical trials gives Serbian patients access to novel biologics, which are still limited under the state-funded supply programs, furthering their motivation
  • A GMP certificate is sufficient for regulatory submissions and the European Union’s QP Statement is not required

Cromos Pharma’s Services in Serbia:

What we do

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Patient recruitment
Patient recruitment
  • Promotional and educational materials
  • DTC outreach
  • Investigator’s materials
  • Booster visits
  • Referral sites
  • Commitment to patients
  • Patient’s materials
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Clinical Research Services
Clinical Research Services
  • Capability and Feasibility Assessment
  • Project Management
  • Monitoring Services
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Regulatory Services
  • Compilation of initial documents for RA and ECs/IRBs
  • Review of IC documentation
  • Obtaining of trial subjects’ insurance
  • Secure import/export licenses
  • Regional regulatory consultation
  • Regulatory strategy and clinical development planning
  • Submissions to Regulatory Agencies
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Medical Writing
  • Study concepts and outlines
  • Clinical study protocols and amendments
  • SAP for inclusion into protocol
  • Investigator Brochures
  • Investigational Medicinal Product Dossiers
  • Patient Informed Consent Forms
  • Clinical Study Reports
  • Executive summaries for efficacy or safety, ISS, ISE
  • Reviews of clinical and nonclinical data
  • Patient narratives, SAE narratives
  • Abstracts, posters, and journal articles
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and data
Data Management
  • CRF development/validation
  • Customized database design/validation
  • Data entry screen design/validation
  • Double data entry
  • Programming under SAS
  • Data validation
  • Data listings
  • Convenient data format for the client
  • Data transfers
  • Data coding
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CTM Logitics
  • Full Scope of Clinical Trial Logistics Services
  • Controlled access to storage areas
  • 24/7 receipt of IMP and CTM
  • Patented warehouse database program
  • General liability and property insurances
  • Compliance with ISO 9001:2015 & GDP
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PV Support
  • Therapeutic, technical, and operational excellence
  • Tailored and cost-effective safety solutions
  • Flexible outsourcing of safety functions
  • A team of QPPVs for registered products in EU
  • Updated country-specific regulatory requirements
  • Robust quality system
  • Pharmacovigilance consultancy
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Independent Audits
  • Clinical site GCP audits
  • Documentary Trial Master File audits
  • System Vendor Audits
  • Regulatory Inspection and Sponsor’s audit readiness check


Belgrade office

GTC 19 Avenue 38-40 Vladimira Popovica Street, Belgrade 11070, Serbia

Tel: +381 11 4220 633

Serbia Country Profile

Serbia – a land of opportunity for clinical research
The past, the present, and the future When someone mentions Serbia in a scientific context, the name of Nicola Tesla inevitably comes to mind. But very few people know that Serbia has produced some of the truly great minds in medicine. One such scientist is Miodrag Radulovacki, who is considered to be the father...
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