The aim of the Clinical Research Coordinating Center within the university’s RDI ecosystem is to simplify and streamline the administration of the clinical trial start-up process, to support patient recruitment, to implement new technology and digitization and to strengthen collaboration with industry players.
Speeding up administrative and authorization procedures is also an important factor in providing efficient and seamless operation. The Center additionally provides internal quality management. Overall, it monitors and supports the entire clinical development process from the initial inquiry throughout the contracting and conducting phases to the closure of the trial.
For early-stage clinical developments, Semmelweis University established three Phase I Units accredited by the competent authorities. In accordance with the current regulations in Hungary, all Phase I Unit leaders are qualified clinical pharmacologists. The Phase I Units are at the Department of Internal Medicine and Oncology, the Heart and Vascular Center, and the 2nd Department of Pediatrics. Along with the Phase I Units, Semmelweis University’s clinical departments perform close to 200 clinical trials every year. More than 3,000 active clinical trial patients per year benefit from innovative diagnostics and therapy. The University also works in close cooperation with key opinion leaders to support scientific oversight and to decide on the optimal operational delivery and clinical trial execution.
Besides clinical trials in new therapeutic areas the Center’s core strategic objectives are implementing digitization, supporting the application of new technologies, such as remote monitoring possibilities, decentralized clinical trials execution, e-consents, e-patient internal recruitment, and referral systems.