Countries of Operation: Ukraine

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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
million
(2023)
Total population
36
initiated clinical trials
in 2022
72.5
years
(2023)
Life expectancy
Main advantages of conducting 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

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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