A global cell and immunotherapy company was required to manage phase 2 clinical trials in the US and Israel. There were several logistics requirements for these clinical trial shipments:
- Domestic shipments within Israel in needed be transported in refrigerated condition between +2°C to +8°C.
- International shipments from Israel to the US and the Netherlands needed to be transported in two different temperature ranges: controlled room temperature between +15°C to +25°C, and refrigerated condition between +2°C to +8°C.
To ensure shipments were delivered at the required time, within the correct temperature ranges, Royale International identified the key challenges:
1. Ensuring all parties involved; airlines, customs brokers, cargo terminals, ground handlers, local distributors, were executing their procedures according to the GDP (Good Distribution Practice) requirements.
2. Providing suitable thermal packaging with a validation time that met the shipment routing, timeframe, and/or product lifespan.
3. Avoiding mishandling, errors, and temperature deviations throughout the entire shipping process.
To overcome the above challenges Royale International utilised its Global Quality Management System:
1. Only qualified and approved airlines were used for routing from Israel to the US and the Netherlands.
2. Royale made use of validated and robust thermal packaging with a long validation time.
3. Each thermal package consisted of two calibrated data loggers (1 data logger as backup).
4. All shipments were monitored by our online monitoring devices.
After over 100 successful shipments, the client is now in the data analysis phase and are looking to kick-start their phase 3 clinical trials with the reassurance that Royale International will lead this project from a logistics perspective.
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