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Our Experience as a Full-Service Contract Research Organization (CRO)

Designing and preparing research documentation for Class III medical devices quality control:

    • Clinical study protocol design in accordance with the ISO 14155 and Ukrainian legislation
    • Investigator brochure and IFU in accordance with the ISO 14155
    • Informed Consent preparation for patients
    • Insurance agreement preparation
    • Patient recruitment optimization

Approval process with the State Administration of Ukraine on Medicines and Drugs Control:

  • Preparation of all additional documentation (including PoAs, Clinic profile, application forms, etc.) in accordance with legislation and international standards

Study Implementation in the Ukrainian Children’s Cardiac Center, Clinic for Adults:

  • Development and submission of appropriate documentation and obtainment of the Local Ethics Committee approval
  • Agreement between the CRO and sponsor
  • Agreement between the Sponsor and hospital
  • Patient recruitment and Informed Consent notarization

Import of Study Devices:

  • Management of the invoices and import/export licenses
  • Organization of custom brokers services

Clinical Study:

  • Continuous protocol compliance control
  • Adequate subject enrolment
  • CRF

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