Boyan Clinic
Currently IPR-EE operates two clinical sites, on at Boyan, close to Chernivtsi Ukraine and one in Chisinau, Moldova.
Since spring 2004 PPN-UA is registered and licensed as private clinic which is specialised and exclusively used for clinical research. The clinical area can be extended up to 30 clinical beds.
The IPR-EE clinical site in Moldova is located at the National Institute of Cardiology in Chisinau, Moldova and will be extended up to 24 clinical beds during 2006.
The IPR-EE clinical sites have experience in the conduction of phase I, II and the clinic areas are exclusively used for the conduct of clinical trials. So there is no competition of clinic beds with patients entering the clinic for therapeutic purposes. There is a team of physicians and nurses, which is trained to conduct clinical trials. These teams are involved in all clinical trials performed in the clinical sites. Most of the physicians are anaesthetists/cardiologists and worked in emergency medicine for many years. All trial nurses are also trained in emergency medicine and have practical experience in the treatment of patients in emergency care units. Thus maximum safety is provided for hospitalised patients in clinical trials. The clinical part of the trial is supervised by a local quality control team to guarantee the conduct of clinical trials according to the protocol, local laws, SOPs and international guidelines. The clinical- and quality control teams are supported by a project management group caring about administrative matters as well as commenting documents, performing translations, submission of documents for approval and supervision of deadlines. Two pharmacists are responsible for correct storage and accountability of the trial medication. In total there are currently 26 full- and part time employees.
The overall management of IPR-EE and its clinical sites is supervised by Dr. Franz Janik. Dr. Franz Janik was trained in biology and pharmacology and has 18 years experience in pharmaceutical industry.
Responsible for the quality of the IPR-EE clinical sites is Dr. Karl M. Eckl, former Medical Director of Pharm PlanNet Contract Research GmbH in Mönchengladbach. With 20 years of experience in clinical research of phases I, II and III, Dr. Eckl was responsible for more then 300 clinical trials as investigator or sub-investigator.
Medical responsibility for the clinical team in Ukraine is covered by Prof. Semen Biletski, a well known internal specialist and cardiologist in Ukraine. Prof. Michail Popovicii head of the National Institute of Cardiology in Chisinau Modlova has medical responsibility for the clinical team in Moldova . Both clinical team leaders are members of the local medical universities.
Prof. Biletski gained experience in the conduction of clinical trials as investigator in phase I and phase III clinical trials.