A logistics concept including implementation of a Europe-wide Phase II study for a candidate biotech product.

The Challenge

The sponsor, an Austrian biotechnology firm required a partner for the logistical planning and execution of a Phase II study for a candidate product in Austria, Croatia, Germany, France, the Czech Republic, and Slovakia. The clear requirement here: Eliminate the possibility of temperature deviations in transport, and control costs over the course of the study.

Our Solution

As part of our mandate we decided to use high-quality passive packaging for international shipments which were served with a regular express service, and a lower-cost passive packaging system to supply Austrian study sites using actively cooled vehicles with an interior temperature of 15-25°C.

Furthermore, in the course of realising the project we arranged the following aspects with the sponsor with respect to the exact process documentation and checklists, to ensure full traceability of all deliveries:

• Coordination and notification of possible ordering dates with respect to delivery dates, especially for destinations with delivery lead times greater than 24 hours
• Selection of temperature loggers and configuration of the monitoring of each individual IMP delivery, as well as of refrigerators at the study sites
• Design of enclosed documentation
• Definition of the external labelling of the shipping container to simplify identification of the study site, and enable association of the delivery with the study