Following a major earthquake (8.9 on the Richter scale) that struck Japan, the Fukushima Daiichi nuclear plant suffered severe damage to multiple reactors. Due to the damage at the nuclear plant and other serious damage caused by the tsunami, service to the main cities and prefectures of central Japan was dramatically curtailed. The combination of the effects of the tsunami and the grave situation at the nuclear plant made it critical for Marken to develop a contingency plan for the pick-up and delivery of clinical trial specimens and the delivery of clinical trial materials to investigator sites in safe areas of the country.
Marken’s first step was to relocate the Japanese office from Tokyo to Osaka and transfer all phone and fax communications to the new office. For safety reasons, Marken would only authorize drivers to collect and deliver shipments in areas declared safe by local authorities. The move of the office to Osaka put Marken personnel outside the danger zone and closer to Kansai International Airport (KIX), which would temporarily become the hub airport for Marken’s shipping activities. Since no export license was required for biological samples, it was possible to export from any international airport in Japan with just a pro forma invoice. This made it possible to use KIX as a gateway with minimal impact on the export of specimens.
For clinical trial kits and Investigational Medical Products, a Clinical Trial Certificate is granted by the PMDA (Pharmaceuticals and Medical Devices Agency) to import clinical trial materials into Japan. Since these documents are not specific to the point of entry, Marken’s clearing agent simply needed to provide a copy of the original document for each shipment entering Japan regardless of the airport of entry.
There was one additional complication in the proper handling of samples: because of the extensive damage to the regional infrastructure of Japan, there was a chance that there would be a dry ice shortage, which could potentially compromise the integrity of samples that needed to be stored or shipped within tight temperature ranges. Marken made a provision to extend the supply of dry ice in the affected area. In the event of a nationwide shortage of dry ice, Marken had a contingency plan in place to move dry ice into Japan from neighboring countries on a daily basis.
While the earthquake did disrupt deliveries and pick-ups in the affected zones, Marken was able to provide on-going service to its customer base in the other parts of Japan.
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