Center for Phase I Clinical Trials at Tartu University Clinic
EGeen has a preferred access to the Phase I Clinical Trial Center at Tartu University in Estonia.
Tartu University Clinic is a pioneer in clinical trials in Estonia since first clinical trials were conducted there in 1992. Since then, several phase I trials and more than 200 phase II-IV trials have been carried out at various departments of the Clinic. The Center for Phase I Clinical Trials specializes in phase I trials in all therapeutic areas and was opened in the beginning of 2004. The centre has been audited by an outside audit in 2004.
Staff
The Center is directed by Prof. Rain Jõgi, MD PhD, Head of the Lung Clinic. The permanent staff is comprised of three research nurses and one research assistant, all with extensive experience in clinical trials and other research projects. Resumes of the permanent staff of the Center can be provided. An anaesthesiologist from ICU, and, when necessary, additional nurses and doctors will participate in trials. All members of the team have experience in clinical trials.
Facility:
The Center is located at the Tartu University Hospital campus. There are 24 hour security guards at the main door and at the inner door of the building, and all rooms are electronically guarded. The Center is isolated from any other patients and is operational for 24 hours/7 days a week.
Patient Areas:
The Center currently has two large lounges and two bedrooms for 12 volunteers and one room for study nurses. The volunteer facilities are equipped with TV, computers with internet connection, a refrigerator, a microwave, and a coffee machine. If required, a standard meal preparation can be arranged.
Drug and Sample Handlings
The investigational medicinal products (IMPs) are stored in a secure cabinet in the study nurse’s room which is always locked. IMPs can be handled directly at the Center without a need for pharmacy. IMP administration and blood sampling, centrifuging and storing of the samples take place at the Center premise.
Center Facilities:
The Center is equipped for emergency including a defibrillator and the other emergency medical equipment and supplies on site. If needed, additional equipments (e.g., ECG) can be installed for specific trials. For storage of IMPs and the samples, the Center has a centrifuge, a refrigerator, –20oC and –70oC freezers equipped with lock and alarm. The temperature log is regularly maintained. The unit has secure storage space for study-related material (e.g. CRFs) and additional storage space at the hospital is available for long term archives.
Support Facilities:
The physical exam and screening of the volunteers can take place at the main hospital or at the Centre.The central laboratory of Tartu University Hospital is in the main hospital building and was certified by the Estonian Ministry of Social Affairs on January 27, 2003. The laboratory has significant experience in analysis of the samples from clinical trials. The laboratory can provide safety and microbiological analysis. Additional analysis protocols can be easily implemented, if needed.
