Clinical Investigation
Albert Szent-Györgyi Clinical Center
Department of Dermatology and Allergology
Clinical Investigation Unit
The clinical-pharmacological research studies, examinations play a significant role within the Theoretical Institutes of the Faculty of Medicine and the Clinics of the Albert Szent-Györgyi Clinical Center.
From 2010 on a totally restructured Clinical Research Coordination Center (CRCC) - previously established within the confines of the University of Szeged - has been operating.
The Center is led by Lajos Kemény M.D., D.Sc., Professor, Department of Dermatology and Allergology.
The Clinical Research Coordination Center handles current clinical research studies: keeps continuous contact with the CRO partners and clinical research contact persons from various study sites.
Beyond the full management and registration of institutional contracts we have also worked out a complex coordination system for examining process and a new medical referral system that has also been in action in order to increase the number of outsider patients involved in various studies in the future.
The above mentioned services are eligible options for any Investigators or even Sponsors. After all, our Center can play the Site Management Organization role with all advantages of internal established firms, without any disadvantages of officially outsourced services.
As an improvement of the coordination model each study involves two own permanent coordinators in order to execute administrative duties, and of course the professional supervision of the Center, which means a great support to the examining doctor, making it possible to them to involve more patients without extra oppression. Study management means that the office is taking all responsibility for its duties from the phase of feasibility till the final closing visit, as well as the operation of the referral system.
The main activities of the Center:
Giving general information about the process of the clinical study contracts.
Full management and registration of institutional contracts.
Organize the meeting points with external or outsourced participants, eg. contacting with the Department of Laboratory Medicine, Institute of Clinical Microbiology, or the Radiology Department.
Keep in touch with the Regional and Institutional Human Medical Biological Research Ethics Committee.
Keep in touch with the contact persons, CROs or CRAs.
Organizing meetings for the Discussing Committee of the Clinical Research Contracts and other meetings, deals with the clinical research studies.
Fulfillment of the coordination role towards the Medical Academic Council.
The complex coordination system can be adapted for studies, including documentation capacities and 24 hours call-on-duty management.
High number of general practitioners (GPs) and specialists can be asked for referring patients to the nominated trials by the Referral System Group.
With the cooperation of qualified examiners we are proud to offer our support in all fields of clinical trials. In each and every study the Clinical Research Coordination Center and its office is the guarantee for the successful and precise execution.
Our staff and the scope of duties:
| Lajos KEMÉNY M.D., D.Sc. President | |
| Balázs BENDE, MD Clinical Research Coordinator | Restructuring of CRCC, development and operative realization of innovative plans. Continuous coordination and contacting with ongoing projects and lead study coordinators. |
| Erika SAJTINÉ BALOGH Chief Clerk | Administrative and registration duties of the Center, contacting with separate departments of the University of Szeged, full management of contracting. |
| Réka SZABÓ Public Relations | Development and realization of direct marketing plans, complex design and branding, organization of communication trainings. |
| Rita KOVÁCS, MD Referral system coordinator | Organization of the referral system between primary care and partner professions, getting up trainings and dissemination towards the GP system. |
| Mónika VISNYEINÉ DANKÓ Clinical Trial Assistant | Administrative background study management. |
| Gábor VOLFORD, MD Lead Study Coordinator | Insurance of the human resources for coordination positions, surveillance and organization of trainings and small-scale audits. |
| Anita ORHA Study Coordinator | The complex coordination of recently ongoing projects started in the newly established coordination system, training of coordinators, contacting with CROs. |
| Zoltán SÁDT Study Coordinator | The complex coordination of recently ongoing projects started in the newly established coordination system, training of coordinators, contacting with CROs. |
| Péter SIPOS Study Coordinator | The complex coordination of recently ongoing projects started in the newly established coordination system, training of coordinators, contacting with CROs. |
