Organizing and conducting clinical trials

For those who need to register a clinical study of a cell or tissue products of own production or to obtain permission for the use of cell or tissue products in Ukraine, the Institute of Cell Therapy has Department of Clinical Research in the R&D Center, whose highly qualified specialists can provide the following services:

Services:

1
Preparation and registration of the complete package of documents

Which must be submitted to the Coordination Center for the Transplantation of organs, tissues and cells of the Ministry of Health of Ukraine in accordance with the requirements of the Order of the Ministry of Health of October 10, 2007 No. 630./p>

2
Adaptation of the clinical researches

Adaptation of the clinical researches protocol of the client’s/Customer’s cell or tissue products to the requirements of the legislation of Ukraine and submission of it as a part of the complete package of documents for consideration by the Coordination Center for the Transplantation of organs, tissues and cells of the Ministry of Health of Ukraine

3
Consultation and support of the Customer Company

Consultation and support of the Customer Company during the submission of documents to the Coordination Center for the Transplantation of organs, tissues and cells of the Ministry of Health of Ukraine in order to obtain a permit for the clinical study of a cell or tissue products

4
Search of clinical sites

Search of clinical sites, which meet the study conditions/requirements (??), and conclusion of contracts with them for carrying out of clinical trials on behalf of the Customer (by agreement of the parties)

5
Consultation|conversation with ethical committees

Consultation|conversation with ethical committees of clinical sites that meet the requirements of the study for obtaining a positive decision for clinical studies of cell or tissue products

6
Search for patients

Search for patients who meet the inclusion criteria in the clinical trial

7
Cell or tissue products delivery

Cell or tissue products delivery, storage it in proper conditions in accordance with the requirements of the protocol, thawing and preparing (e.g., washing, re-formulation) for transplantation, final quality control (e.g., sterility, endotoxin testing), transport packaging in the R&D Center of the Institute of Cell of Therapy, at its high-tech base, transfer of prepared cell or tissue products to clinical sites in Kyiv and around Ukraine

8
Documentary support of the clinical trial of cell or tissue products

Documentary support of the clinical trial of cell or tissue products in accordance with international standards and requirements of Ukrainian legislation. Timely submission of reports on a clinical trial of a cell or tissue products to the Coordination Center for the Transplantation of organs, tissues and cells of the Ministry of Health of Ukraine

9
Preparation of documents in accordance with the legislation of Ukraine

Preparation of documents in accordance with the legislation of Ukraine for submission to the Coordination Center for the transplantation of organs, tissues and cells for obtaining permission of Ministry of Health for the technology of the use of the cell or tissue products of the Customer in Ukraine, if clinical research was successfully completed in other countries

10
Post-registration documentary and logistic support

Post-registration documentary and logistic support of the cell or
tissue products in Ukraine

11
Development of protocols for preclinical and clinical studies

Development of protocols for preclinical and clinical studies of cell
and tissue products

12
Organization, conducting and monitoring of clinical studies

Organization, conducting and monitoring of clinical studies of own and contract cell and tissue products in accordance with the requirements of the current legislation of Ukraine

13
Processing, including statistical, final data obtained

Processing, including statistical, final data obtained in the course of clinical trials. Writing, processing and submission of final reports to the Coordinating Center for the Transplantation of organs, tissues and cells of the Ministry of Health of Ukraine in order to obtain permission for the use of clinically proven technology for the application of cell or tissue products

14
Preparation of a cell or tissue product dossier

Preparation of a cell or tissue product dossier for registration at the control authorities of other countries

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