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