The Jagiellonian Center of Innovation has many years of experience in the field of implementation
clinical trial projects for pharmaceutical companies and medical devices manufacturers. We have been operating in the clinical trials market since 2013, when we created the JCI Clinical Trials Center. From the beginning, we have been acting in compliance with the highest international standards, taking care of the highest quality of services.
So far, we have carried out trials both for leading international pharmaceutical companies as well as small local biotechnology start-ups.
Together with our business partners, we have launched a comprehensive service for entities interested in implementing projects involving patients. This service includes the design and implementation of:
- medical experiments
- clinical trials
The offer includes:
- preparation of complete trial documentation for the purpose of obtaining consent from the Bioethics Committee and the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- managing the trial project, including the preparation of accompanying documentation required for a given trial, such as CRF or patients’ personal record cards
- trial monitoring
- carrying out the trial at the JCI Clinical Trials Center
The offer is dedicated to manufacturers of medical devices, including well-being solutions.
Start-ups operating in the pharmaceutical and cosmetic market are also welcome to contact us, should they be interested in clinical confirmation of product indications.
In addition, as part of the support services for clients of the Clinical Trials Center, we offer:
- assessment of the functionality of the medical device design with the requirements of the MDR Regulation and compliance assessment identification
- coordination and supervision of the process of designing medical devices
- assistance in planning and coordinating laboratory tests – we have 6 laboratories equipped with analytical facilities,
- preparation of technical documentation, in accordance with MDR annex II + III
- production of substance-based medical devices and cosmetic products, if applicable