Countries of Operation: Croatia

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Bulgaria Bulgaria
Croatia Croatia
Czech Republic Czech Rep.
Estonia Estonia
Georgia Georgia
Hungary Hungary
Kazakhstan Kazakhstan
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Lithuania Lithuania
Moldova Moldova
Poland Poland
Romania Romania
Serbia Serbia
Slovak Republic Slovak Rep.
Slovenia Slovenia
Türkiye Türkiye
Ukraine Ukraine

Croatia has a rich heritage in terms of science and good clinical research experience

Croatia provides a natural conduit between EU and non-EU countries, providing an advantage of the Croatian language which is easily understood by the non-EU countries surrounding it. Croatia has a rich heritage in terms of science and good experience in clinical research. As a result, many contract research organizations (CROs) chose Croatia  to conduct clinical trials.

Croatia Quick Facts
3
doctors
(2023)
per 1 000 population
5.5
hospital beds
(2023)
per 1 000 population
4
million
(2023)
Total population
45
initiated clinical trials
in 2022
79
years
(2023)
Life expectancy
Main advantages of conducting clinical trials in Croatia:
  • EU directives are incorporated into Croatian legislation
  • High patient recruitment potential
  • Rapid accrual, often using less sites than the neighboring CEE countries
  • Highly qualified and experienced medical staff
  • Reliable start-up timelines and timely enrollment
  • Proven track record in the conduct of clinical trials in accordance with the GCP standards

Cromos Pharma’s Services in Croatia:

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
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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EU legal representation
EU legal representation
  • Your clinical gateway to Europe
  • Legal representation in EU/EEA
  • QP Statement obtainment
  • Cost-effective and time-saving services
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Medical
Writing
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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Biostatistics
and data
management
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
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
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
Independent Audits
  • Clinical site GCP audits
  • Documentary Trial Master File audits
  • System Vendor Audits
  • Regulatory Inspection and Sponsor’s audit readiness check

TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM

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