Highly motivated and well trained IMP managers handle all IMP orders and oversee all shipments to investigator sites in compliance with legal requirements, Good Distribution Practice (GDP), and trial related IMP specifications. Global distribution using most reliable courier support is offered for international trials. All IMP supply procedures are documented without gaps to afford full traceability of the SSU. IMP availability (on stock and shelf-life) is electronically monitored and alarmed.
Times from IMP order to dispatch at the investigator sites are minimized and are within 24 hours for all countries with warehouses. Transports to locations in non-EU member states can be operated within less than 72 hours.
- Requests from investigators by fax, web-based systems (IWRDS), or phone-based systems (IVRDS) for IMP assignment and resupply
- Use of trial specific request and delivery forms
- Release for IMP supply by project manager
- Pick and pack within 24 hours after request
- Monitoring of shipping conditions (temperature logger)
- Confirmation of receipt by investigator within 24 hours (fax, email, IWRDS, IVRDS)
- Green light procedure for critical IMP implemented according client request
- Just-in-time delivery (national: 12-24 hours; international: 24-72 hours)
- Cool vans operating direct shipments in central European countries
- External courier services in peripheral European countries and overseas
- Tracking of request and shipping status