Principal investigators/investigators
Several highly qualified principal investigators and investigators participate in the work of the centre who have great experience in clinical studies in the following fields: Internal Medicine, Pediatrics, Obstetrics and Gynecology, Pulmonology, Infectology, Hepatology, Allergology, Dermatology, Intensive Care, Emergency Care, Traumatology, Ophthalmology, Ear Nose & Throat, Surgery, Neurology and Psychiatry.
Institutional authorization and research documentation
The institution has introduced a central authorization system which has been in use for clinical studies since 2003, in line with effective legal stipulations and adapting to changing regulatory environment. The sheet necessary for authorization by the head of the institution can be downloaded from our website. The uniform study authorization is provided after the necessary documents have been submitted.
- Clinical studies
- Phase I-II-III-IV national and international clinical studies related to drugs, food and medical devices
- Study of bioequivalence and biosimilars
- Study design, selection of study sites, providing principal investigators
- Authorization/advising
- Contacts with principal investigators (training of investigators)
- Organization of patient recruitment
- Study site management and monitoring, standard procedures, checklists
- Data processing, clinical study administration
- Electronic information systems
- Pharmacovigilance (drug safety)
- Design, organization, and adaptation of drug safety systems
- Continuous monitoring of drug safety (adverse events, side effect reporting, periodic reports)
- Quality assurance of clinical studies
- Implementation, planning and adaptation of quality assurance systems
- Review of clinical studies by EMEA and EOQ-qualified auditors
- System audit
- Compliance-to-System audit
- Study data report audit
- Occasional audit
- Organization of seminars in GCP and quality care
- Preparation of standard procedure regulations of clinical trials (study site, monitor)
The institution has developed and operates its quality assurance system in line with the MSZ EN ISO 9001:2001 standard and Hospital Standards of Care (KES) and it provides for its continuous development in order to improve efficiency and satisfy customer needs as much as possible."