Project implementation at the JCI Clinical Trials Center

The Center’s personnel:

• Chief Investigator/s at the level of general specialization from: oncology, gynecology, dermatology, orthopedics, cardiology, infectious diseases, paediatrics, vaccinations, rheumatology
• Collaborating researchers: radiologists, ophthalmologists, GPs
• Personnel related to the implementation and handling of clinical trial projects: clinical trial coordinators, 2 pharmacists/ also – clinical trial coordinators, coordinator/paramedic, imaging coordinators/receptionists, nurses, front desk personnel, imaging technicians
• Additional supporting personnel: radiation protection supervision, sanitary and epidemiological conditions supervison, medical physicist,
• Monitoring of clinical trials, cooperation with freelance clinical trial monitors

The possibilities of the Center along with its infrastructure:

• an organized unit based on standard operating procedures (SOP), constant monitoring of the validity of certificates and equipment calibration (documentation available immediately upon request)
• equipped with its own Imaging Laboratory (CT, MRI, ultrasound and its own Densitometry Laboratory)
• fully equipped, modern doctor’s offices and a training part, including a conference room for up to 96 people (auditorium), dedicated IMP room, medical records archive
• patient room (3 beds), no possibility to perform procedures in hospital conditions
• drug warehouse with -80°C freezer with continuous, double-secured temperature monitoring (the temperature of freezers and refrigerators is measured every minute with available records), IMP warehouse equipped with a dual emergency power supply system (additional Tauron line and two generators)
• Institute of Genetic Engineering located in one of the laboratories of the premises. This facility gives the opportunity to conduct clinical trials with registered IMPs as genetically modified microorganisms (GMM), according to Polish legal regulations. The Institute is equipped with all elements required by law, as well as:
  • refrigeration equipment with temperature recorders, which enable remote recording of temperature continuously (every 10 minutes) and interval recording of maximum and minimum temperatures
  • a laminar flow chamber (class II) that allows IMP preparation when aseptic conditions are required
  • the implemented procedures ensure safe and legal compliance of the circulation and management of the IMP (investigative medicinal product) at the facility
  • a dedicated on-site pharmacist who is responsible for the IMP and appropriate storage conditions at the Institute of Genetic Engineering

The Center is prepared to carry out trials in particular specializations – considering the above-mentioned limitations (no possibility to perform procedures in hospital conditions) – each time it requires arrangements with the CBK Governing Bodies: