Managing Drug Supply and Biosamples

PSI offers a comprehensive range of clinical trial supplies services in different parts of the world. PSI has drug storage facilities both within the European Union, as well as in Russia and Ukraine to facilitate running of clinical trials in those countries.

For non-EU clients PSI serves as a point of entry for investigational products entering the European Union.

PSI’s capabilities in clinical supplies management include:

• Life cycle management
  • Product forecasting and planning
  • Third-party packaging and labeling vendor management
• Qualified Person
  • QP Consultancy and analytical services
  • Product batch release
• Secondary packaging and labeling
  • Secondary packaging of study drugs and comparators
  • Drug labeling in multiple languages
• Global procurement and distribution
  • Temperature-controlled warehouses
  • Purchasing commercial and ancillary products
  • Import/export coordination within and outside the EU
  • Controlled environmental chambers
  • Refrigeration and freezer storage (down to -85 degrees Celsius)
  • Global distribution of study supplies
  • Drug reconciliation and destruction

Secondary packaging
Secondary packaging area

• Labels storage area
• Quarantine areas prior and post labeling
• Airlocks (for assuring adequate supplies flows)
• Labeling area
• QC of the labeled IMPs area

Drug storage options
Drug Storage area

• Full range of temperature-controlled storage options (ambient 20 +/-5°C, refrigerated storage 5+/-3°C, frozen storage -15°C to -25°C and deep frozen storage -60°C to -90°C)
• Separate areas for Quarantined, Returned, Counterfeit, Rejected and Recalled drugs
• Order Processing area for all the shipments dispatched
• Gowning/ Un-gowning area for personnel

Ambient storage
Ambient area

• Security systems:
• Access control system (restricted access with computerized access logs)
• Alarm system (motion and break-in detectors)
• Iron bars
• Digital monitoring system with computerized temperature and humidity recording at 5-minute intervals
• Electrical back-up generator
• State-of-the-art Fire Detection and Extinguishing System
• Complex HVAC system
• Pest control (UV lamps, Ultrasound devices, traps)
• Lockable, fire-resistant, metallic cabinets, numbered and labeled on a per project basis

Refrigerated storage
Refrigerated storage area

• Walk-in cold room with segregated areas (including for quarantine and labeling)
• Aluminium shelves identified by number and labeled with the project code

Hands-on, experienced staff
Qualified and highly experienced in pharmaceutical and CT industry

• Head of Production
• Clinical Supplies Managers
• Qualified Person
• QC Pharmacists
• Pharmacists
• Clinical Supplies Assistants
• Annual training program in GMP, GDP, PSI and client SOPs