Expanded Access: Coordinating Complex Deliveries of Lifesaving Clinical Drugs

CHALLENGE

A very sick pediatric patient in Cordoba, Argentina, needed a compassionate use drug that required a highly trained medical professional to carefully inject the clinical drug into the brain on a specific time and day. Expanded access programs, sometimes referred to as compassionate use, allow eligible patients to receive an investigational medical product outside of a clinical trial when no other treatment options exists.

Marken was notified about this complex shipment with less than 48 hours before the patient was to receive the injection and had to quickly develop a plan to ensure the drug arrived safely and on time. The shipment was due to initially arrive from the Netherlands into Buenos Aires, 800 km northwest of Cordoba. Due to the sensitive nature of the drug, temperature requirements and the absolute timeline to administer the drug to the patient, a dedicated driver was assigned for the route from Buenos Aires to Cordoba. Meticulous coordination and communication with the driver included a detailed series of delivery instructions and plan.

The brief notification period for this shipment provided only a small window to translate the information into Spanish for the driver as well as train him on the specific procedures for the drug and the delivery strategy to the hospital.

Additionally this shipment was the first of this type of clinical drug worldwide, so no precedent or previous process existed.

 

SOLUTION

Marken’s local Logistic Quality Coordinator based in our Buenos Aires office trained the driver on the specific process for this drug. The documents were translated within a short timeframe from English to Spanish to ensure there were no language challenges with the delivery. Upon completing the project-specific training, the driver was dispatched to Guarulhos International Airport to wait for the shipment to clear Customs and begin the eight hour drive to Cordoba. The driver arrived in Cordoba early and waited to drop off the shipment as the delivery time requested by the client was specific. On the day of the delivery, Marken’s local Logistics QC Coordinator also flew from Buenos Aires to Cordoba to meet the driver at the time of delivery to oversee the handover of the medication on site and to confirm all steps were performed as required. This extra attention and oversight ensured there were no issues with the delivery of this highly valuable shipment to the sick child.

 

OUTCOME

Marken successfully delivered a compassionate use drug to a waiting pediatric patient within a short timeframe despite location and language challenges. The client, patient and family were appreciative of our flexible service, quality and commitment to the delivery.

Marken’s global logistics network offers the capability to assist patients around the world who may be participating in these types of compassionate use and expanded access programs. The personal dedication of Marken team members truly Makes It Happen for patients who place hope in every vital new treatment we deliver.

 

Talk to us about your logistics challenges

Email: expert@marken.com

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