Back Direct-to-Patient Clinical Trial During Unprecedented Circumstances
A young patient in the Bahamas needed a special therapy to treat a rare form of epilepsy.
The challenge was to deliver the therapy before Hurricane Isaias hit and limited flight options due to COVID-19.
QuickSTAT was able to successfully deliver the therapy by conditioning a shipper, identifying the most viable route, providing regulatory guidance, monitoring temperatures, and providing ongoing communication.
A pediatric patient in the Bahamas needed a special therapy to treat a rare form of epilepsy. As his family watched Hurricane Isaias increase in strength as it made its way toward the country, they were worried about getting their son’s treatment before the storm hit. This time pressure was further exacerbated by already limited flight availability due to the lingering impact of COVID-19 around the world. Added to this, the therapy had to be kept at 2º to 8ºC throughout its journey.
To successfully outrun Hurricane Isaias despite the number of grounded flights resulting from COVID-19 shutdowns, QuickSTAT worked with the drug sponsor company to expedite delivery, which included:
- Conditioning a 2º to 8ºC Phase Change Material (PCM) shipper designed specifically for refrigerated products
- Identifying the most viable route given the hurricane and limited flight options to ensure the therapy would reach its destination before the storm shut down airports
- Providing regulatory guidance and assisting with the necessary paperwork so that the therapy cleared customs as quickly as possible
- Monitoring temperatures from the point of collection through to delivery to the patient’s home for his treatment
- Ongoing communication, informing all parties involved of key milestones throughout transit – from pick-up until it arrived at the patient’s home
- The young patient was able to receive the critical therapy he needed ahead of Hurricane Isaias, to the relief of his parents