The aims of our Center
The aim of the Competence Centre for Drug Development and Clinical Trials (formerly Clinical Research Coordination Office) is to help both sponsored and academic clinical research at University of Szeged. A vast part of our work is about sponsored clinical studies for which we provide management and coordination services in order to support their quick and precise conduction, to reach the planned number of study participants and to increase the number of on-going studies. Within the most prominent clients of our Center are such huge medical companies as Abbvie, AstraZeneka, Bayer, MSD, Novartis, Parexel, Pfizer, and Sanofi.
Beyond clinical studies, our Centre aims at accelerating investigator-initiated trials at our university by helping investigators and researchers with regulatory, quality and management processes of clinical research. Our goals are to increase the number of academic research projects and also to contribute to their high-quality conduction.
Main activities
Central Management
The main activities of the central management team are primarily connected to the preparation, conduction and closing procedures of a study in order to help its smooth and fast execution. These activities are mainly the followings:
§ organizing and holding postgraduate courses for coordinators,
§ maintaining the professional expertise of the study team members,
§ providing on-site monitor for clinical trials,
§ helping the development of clinical infrastructure,
§ helping financial processes of clinical trials,
§ getting and keeping in touch with the regional and institutional human medical research ethics committee,
§ keeping in touch with sponsors, CROs and other study participants,
§ helping academic researchers in protocol writing, preparation of submissions for authorities and ethic committees, etc.
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Site coordination
Our coordinators take over some duties from investigators and sub-investigators: they keep in touch with Sponsors, organize patient visits and are in charge of the administrative tasks of studies. As a result of their work, investigators can enroll more patients, their administrative tasks lessen and work processes can also become more precise.
At our Centre most of the coordinators have a full-time job helping the conduct of clinical trials at 18 clinics of University of Szeged.
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Other activities
Beyond site coordination and full management services, our Centre takes part in such national and international activities and programmes that facilitate the effectiveness of clinical trials. We believe that these activities can contribute to increase the prestige of the University of Szeged, and also to promote the clinical research work countrywide.
Curretly, our Centre takes part in several research projects, most of which are EU financed grants. For example, we are a consortium member in an Erasmus+ grant that aims to develop a curriculum for the academic researchers of the future or we participate in a medical software development with preparation, coordination and management of its clinical trial.
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