Phase I. center
Our phase I investigation site accommodates the following sorts of trials and tests:
- interaction trials
- kinetic trials
- bioequivalence trials
- therapeutic equivalence trials
- "first-in-man" trials
- vaccine trials
- biological therapy
- special disease trials (virology, immunotherapy, selected dermatological diseases, etc.)
- food industry sponsored trials
Equipment and infrastructure available:
- 16 patient beds in 8 modern patient rooms of 18 square meters each, complete with dedicated water facilities and nurse alarm system
- an additional 14 contingency patient beds in 7 patient rooms equipped with TV, mini bar, and internet connection
- video surveillance system, electronic access control
- defibrillator
- two Lungtest 1000 intelligent spirometers, complete with body plethysmograph and provocation module if needed
- one stress ECG machine
- four -20 Celsius refrigerators/freezers
- one -80 Celsius freezer
- one laminair box
- two centrifuges with cooling function
- PCR lab
- a complete range of third party clinical diagnostic facilities
Staff
Flawless implementation of our clinical trials is guaranteed by a fully GCP cleared staff of 12 medical specialist professionals and 16 vocational healthcare workers with many years of clinical trial experience. All medical doctors are certified in two or three speciality areas. Safety of volunteer subjects is ensured by an on-site 24-hour-presence mobile reanimation team. Two clinical pharmacology specialists are standing by for contact 24 hours a day during trial time. Assisting the specialist staff are three study coordinators experienced in electronic data entry.
Our medical and vocational staff keep their knowledge up to date by regularly attending a variety of professional conferences, symposia and conventions.
