Until June 30, 2013, the vice president of the Medical Center of the University of Debrecen had oversight about the clinical pharmacology activities, signed contracts with the Sponsors and interested parties. Considering that this office was traditionally led by an academic professional, by appointment of the president a clinical leader was also involved to support clinical pharmacology.
The Rector of the University appointed by July 1, 2013, Prof. Dr. Zoltán Szilvássy, decided that clinical pharmacology deserves more focused attention so that clinical trials are run more efficiently and successfully, therefore, in his second week in office I became the Representative of the Rector by special appointment to gain oversight and begin a coordinating role for the University.
The first task was to establish standard operating procedures for work flows and processes concerning the implementation of clinical trials. Before drafting the SOPs, we had looked at several other examples of the kind, we received a lot of support and advice especially from our colleagues at the University of Pécs. We have a trained lawyer giving us legal support from the very beginning who is involved in all contracts we sign. Besides establishing seamless operations, strategic development is also of critical importance.