The Heart and Vascular Center of Semmelweis University re-established its Phase I Unit on the 18th September 2018. The Phase I Unit will carry on cardiovascular early-phase clinical studies according to the principles of Good Clinical Practice in healthy adults and special patient populations including, but not limited to first-in-human, dose-escalation, bioequivalence and medical device studies.
The Phase I Unit also involves cardiologist investigators with experience in clinical pharmacology, clinical study coordinators and nurses. A dedicated investigation bed in a single room with the backup of the intensive care unit of the Clinic has been assigned to the Phase I Unit monitored and alarmed 24 hours a day. The local pharmacy and laboratory fulfill all the possible needs of drug storage and sample processing.
The leader and the principal investigator of the Phase I Unit is Professor Béla Merkely, the Rector of the Semmelweis University and the Chairman of the Heart and Vascular Center.
- Study management with seven full-employed clinical study coordinators
- Study conduct with more than hundred full-employed clinicians
- Recruitment of patients / volunteers through various networks
- Experience in conducting of clinical trials (2019 summary: n=70. Phase I: n=0; Phase II: n=6, Phase III: n=26, Phase IV: n=1, device: n=26, register: n=11)
- Phase I unit equipped with 1 bed
- Intensive care unit with 12 beds (accreditation: 18/09/2018, conducted Phase I trials: none)
- Local pharmacy with full capacity
- Laboratory procedures involving centrifuges, -20oC and -80oC freezers, central temperature control & alarm system
- Professor Béla Merkely
- Professor László Gellér
- Associate professor Dávid Becker
- Associate professor Endre Zima
- Consultant cardiologist György Bárczi