Countries of Operation: Romania

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Romania offers many years of experience and vast expertise in conducting clinical trials

Romania has a population of 19.4 million people, which ensures high patient availability. The overall data quality provided by the investigational sites is very high and comparable with that of Western Europe, whereas the monitoring costs and the investigator fees are considerably lower. As the country’s healthcare sector is rapidly growing, more and more sponsors are including Romania in its clinical programs.

Romania Quick Facts
3.4
physicians
(2021)
per 1 000 population
6.1
hospital beds
(2020)
per 1 000 population
19.4
million
(2023)
Total population
92
initiated clinical trials
in 2022
76.5
years
(2023)
Life expectancy
Main advantages of conducting clinical trials in Romania:
  • High patient availability and rapid recruitment timelines
  • High standards of medical education and experienced personnel
  • Highly concentrated and specialized healthcare facilities
  • Cost-efficiency
  • Regulatory and protocol compliance with the most stringent international requirements
  • All considered clinical sites have passed audits and inspections conducted by sponsor, regulatory agencies and/or third parties
  • Nearly all EU guidelines and regulations for medical research have been incorporated into national legislation

Cromos Pharma’s Services in Romania:

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

TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM

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