Countries of Operation
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USA USA
Bulgaria Bulgaria
Croatia Croatia
Czech Republic Czech Rep.
Estonia Estonia
Georgia Georgia
Hungary Hungary
Kazakhstan Kazakhstan
Latvia Latvia
Lithuania Lithuania
Moldova Moldova
Poland Poland
Romania Romania
Serbia Serbia
Slovak Republic Slovak Rep.
Slovenia Slovenia
Türkiye Türkiye
Ukraine Ukraine

Ukraine has a strong track record in clinical research and offers significant and as yet untapped potential for sponsors.

Ukraine boasts several advantages for sponsors considering the country as a location for clinical research. Its alignment with the EU and harmonization with ICH-GCP standards, high standards in education (in particular clinical and medical training), recent national programs aimed at developing a strong clinical research sector, and general economic initiatives aimed attracting international investment make Ukraine an attractive location for international sponsors.

Cromos Pharma began working in Ukraine in 2006 and established a representative office in Kyiv in 2008. Since then, our highly experienced team in Ukraine has consistently delivered exceptional results for international sponsors.

Ukraine Quick Facts
3
doctors
(2023)
per 1 000 population
7.5
hospital beds
(2023)
per 1 000 population
43
millions
(2023)
Total population
36
initiated clinical trials
in 2022
72.5
years
(2023)
Life expectancy
Main advantages to conduct clinical trials in Ukraine:
  • Excellent recruitment potential due to its large population of modern treatment-naive patients in a wide range of therapeutic areas
  • Ukraine is fully aligned with EU standards and directives in relation to clinical research
  • A positive economic environment focused on attracting international companies and authorities committed to supporting clinical research
  • Relatively low-cost base when compared with EU countries and US yet at the same time boasts high quality work and results
  • A well-organized centralized health system which assists rapid patient recruitment
  • A clear regulatory process and authorities that have been working to improve efficiencies resulting in quick approval periods and expedited timelines
  • Large pool of highly skilled and motivated medical professionals fully trained and compliant with ICH GCP standards
  • Large number of well-equipped medical facilities with experience in running international trials
  • Physicians and patients are favorably disposed to participating in clinical trials as a means of accessing novel treatments

Cromos Pharma’s Services in Ukraine:

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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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

Ukraine

Kyiv office

132 Holosiivskyi ave., 14-A office, Kyiv, O3127, Ukraine

Tel: +38 044 391 1745

TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM

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