For Sponsors
For Sponsors
Conducting trials with the highest standards and meeting all ICH-GCP, local and EU law and protocol requirements
Very short execution of all start-up activities (feasibility, contract negotiations, preparing all essential documents etc.)
Highest quality of data
Team of experienced investigators, study nurses, study coordinators and data managers
Site facilities:
3 medical rooms fully equipped for performing study assessments including medical couches.
All rooms are air conditioned and computers, printers, and internet.
Study coordinators office equipped with filing cabinets locked with smart combination locks, NFC keyless readers.
Reception
Kitchen with coffee maker, refrigerator, microwave, dishwasher.
Refrigerators and freezers with a dedicated UPS to provide battery backup and protection for electronic equipment. The UPS automatically switches to the built-in battery in the event of equipment power irregularities.
Equipment for IMP and samples storage equipped in combination locks.
The site is equipped with a system for monitoring, recording temperature and humidity and notifying of alarms and exceedances (SMS/e-mail alerts). A recording panel that allows wireless reading of data from several sensors simultaneously. Built-in real-time clock and recording memory allows autonomous operation of the control panel. In monitoring systems, measurement data is further sent to the main system: local server (LAN, USB) or cloud platform (internet)- data archiving (min. 5 years).
The site has an alarm system that allows 24-hour monitoring in case of attempted intrusion or theft of property.
The site is equipped with smoke detectors that enable early detection of the presence of smoke in a room, allowing for a quick response. In addition to a loud alarm, the sensor also sends a notification to a mobile device, informing the user of the detected threat.
ECG
Body thermometers
Blood pressure monitors
Weighing scale with height meters
Centrifuge
Defibrillator (first aid equipment)
Additional facility used in clinical trials outside the site (approximately 1-10 min):
X-ray
MRI
Local laboratory
Cardiac ECHO
Specialized ophthalmic examination
Hotel for patients and CRAs (near the Site)
Clinical Study Center S.C.
ul. Kamieńskiego 215/U3
51-124 Wrocław
NIP 8952283110 REGON 540762973-00012
RPWDL 000000287651