Drug Supply and Storage

Logistics represents half the battle when it comes to setting up clinical trials in Eastern Europe.  PSI has a solid infrastructure in place to support every aspect of a clinical trial, including various logistical challenges.  In Russia, Ukraine, Romania and Bulgaria, PSI has its own GMP-compliant drug storage facilities used for centralized import, storage and distribution of clinical trial supplies.  Our drug depots run on a global set of SOPs and are managed by qualified pharmacy staff.

The drug depots offer:

• Secure environment, restricted entry with computerized access logs 
• Digital environmental controls with computerized temperature and humidity recording at 15-minute intervals
• Full range of temperature-controlled storage options
  
  • State-of-the-art refrigerators and freezers with high tolerance for voltage fluctuation, high ambient temperature, and heavy in/out traffic; backup refrigerators and freezers
  • Multiple refrigeration modes: +8°C to -10°C; -10°C to -40°C; -40°C to -86°C; programmable defrost 
  • Microprocessor controls with digital readouts 
  • State-of-the art alarm system with programmable setpoints, power outage and temperature deviation triggers, automatic continuous charge battery backup, and auto-dialup to 4 telephone numbers 
  • Built-in temperature recorders with 7-day circular charts and digital output 
  • Dual power supply
    
• Various distribution options, shipments under cold/frozen conditions; maintenance of the cold chain with in-transit temperature monitoring
  
• Computerized inventory with full tracking history
  
• Post-study drug return, reconciliation, and destruction in compliance with local regulations

PSI is the only CRO in Russia with spacious, fully GMP-compliant drug depots that have contributed to the successful completion of 300+ clinical trials the company has set up.