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Hungary is a well established clinical trials market in Europe with proven track record.

Hungary boasts several key advantages for sponsors considering this country as a destination for their clinical research. Its membership in the EU, high educational standards, recent launch of national programs aimed at developing a strong medical research sector, and general economic initiatives aimed at attracting international investment all position Hungary as an attractive location. Each year approximately 20,000 Hungarian patients participate in clinical trials. Cromos Pharma established its office in Budapest in 2016.

Hungary Quick Facts
3.2
doctors
(2020)
per 1 000 population
6.8
hospital beds
(2021)
per 1 000 population
9.5
million
(2023)
Total population
177
initiated clinical trials
in 2022
77.3
years
(2023)
Life expectancy
Main advantages of conducting clinical trials in Hungary:
  • Hungary is an EU member state with a centralized health system that is cardinal to rapid patient recruitment
  • Streamlined regulatory processes and attentive authorities that have been eager to modernize their approach, resulting in fast approval timelines
  • Large pool of highly skilled and motivated medical professionals
  • Excellent recruitment potential across a wide range of therapeutic indications, especially for multi-country trials
  • Excellent track record of producing high quality data as confirmed by positive inspections from the FDA and EMA

Cromos Pharma’s Services in Hungary:

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
icon - eu legal services
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
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Rare and
Orphan
Diseases
Rare and Orphan Diseases
  • Circumventing recruitment challenges
  • Integrated expertise and support – what does this mean?
  • Active engagement with disease-specific societies and support groups
  • Effective use of referral sites

Hungary

Budapest office

Office No 102, Rubin Business Centre, Dayka Gabor Street 3, 11th district, Budapest

Tel: +36 1 808 8078

Poland Country Profile

Clinical Trials in Hungary – Country Profile 2022
Hungary boasts several key advantages for Sponsors considering the country as a location for clinical research. Its membership of the EU, high standards in education (in particular clinical and medical training), recent national programs aimed at developing a strong medical research sector, and general economic initiatives aimed attracting international investment all mark Hungary out...
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TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM

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