Clinical trials

Clinical Trial Management

If you are looking for a competent and trustworthy partner to manage your clinical studies within Ukraine, JERELO is at your disposal!

As a full-service Contract Research Organization (CRO), we can support you at any stage of your clinical study project.

The medical devices

JERELO is highly focused on medical devices. Therefore, we specialize exclusively in medical devices and possess a deep understanding of device-based clinical studies.

Thus, we can provide partnership along with guidance and ensure your successful journey during each and every clinical study phase implementing ISO 9001 certified quality management system. We can collaborate with you to obtain accurate clinical results, make sure that you adhere to the budget and schedule, and play a role in the improvement of data integration and contract management.

Furthermore, we are competent to contribute to the studies from Early Feasibility and First-in-Man to Multicenter Prospective Observational research.

Since every project is unique, the needs and regulatory requirements vary from project to project. Hence, our multidisciplinary team can help you with various types of studies and make sure that your clinical research project is completed in the most optimal way possible.

Our services include but are not limited to, the following:

• Protocol Design and Development
• Investigator’s Brochure Writing
• Development of Instructions for Use
• Designing Case Report Form
• Informed Consent Guidance
• Party Selection
• Investigator Selection
• Management of Clinical Trial Agreements
• Regulatory and Ethics Committee Submissions
• Clinical Project Management
• Clinical Evaluation Report Writing
• Product Training
• Party Monitoring
• Clinical Research Coordination
• Safety Reporting
• Data Management and Statistics
• Clinical Auditing

Area of Expertise

JERELO has extensive experience in medical device studies in a wide variety of therapeutic areas. Profound knowledge of the specific aspects of the device or therapy ensures compliance with high-end standards and facilitates your clinical trial.

The established vast network of Key Opinion Leaders in Ukraine enables us to find the right party and investigators.

Our areas of expertise utilize Class I to Class III medical devices in a wide range of disciplines:

• Interventional Cardiology
• Dentistry
• Gastroenterology
• Neurology & Neurovascular Conditions
• Oncology
• Orthopedics
• Surgery
• Vascular Conditions (e.g., venous, peripheral, etc.)

We are a highly reliable company due to our proficiency and competence. Therefore, our partners can expect clinically sufficient evidence resulting in smooth market access and straightforward recertification of a particular product.