CHALLENGE

During the holiday season, a family in Scotland planned to travel to Pakistan with their small child. The trip involved multiple flights, stops and cities over the course of a month. The child was enrolled in a Phase II, multicenter, multinational study for a rare disorder characterized by progressive neurological damage. The study’s dosing schedule requires that patients receive daily IV infusions which can be conducted in a home environment [after an initial hospitalization].

The family’s travels included stops in countries with complex Customs requirements for the importation of Investigational Medicinal Product (IMP). Therefore, the study sponsor looked to Marken for expertise on how to clear shipments without delay for the child. Time windows for the placement of the shipments defined by the study protocol were tight and had to perfectly align with the family’s travel schedule. Additionally, the child could not be infused until the study sponsor received confirmation of the IMPs integrity after handover in the form of Marken’s trusted logger data.

 

SOLUTION

Marken immediately understood the urgency and time sensitivity of the protocol. Utilizing their global problem-solving flexibility to assist the family on their journey during the holiday, the team developed custom and personalized solutions that simplified the delivery and network of care for the child.

Throughout the process, Marken provided videos, written instructions and live demonstrations by drivers how to pack each of the boxes.

At the beginning of their trip, the child’s parents were provided with conditioned packaging solutions by Marken to enable them to transport the IMP within the protocol’s defined temperature range as luggage on their two flights to Pakistan. In between flight legs, Marken representatives collected the boxes and temperature loggers from the hotels where the family stayed as well as airports in each destination to ensure data could be transmitted to the study sponsor and an infusion could be completed. In addition, Marken coordinated drivers and personalized logistics for the family as they traveled throughout cities with tedious Customs procedures, including Dubai.

Marken representatives met the family again as they started the long journey home to Scotland, providing a nested container and ancillary supplies before their departure. When the family arrived at their next stop, Marken was there to gather data and immediately communicate it back to the study sponsor so an infusion could be confirmed. After the family’s arrival back in Scotland, Marken collected and returned study materials to the investigator site on behalf of the patient for destruction as outlined in the protocol.

 

OUTCOME

With the well-being of the pediatric patient a top priority, Marken team members maintained constant communication with the sponsor regarding shipment data and infusions. Marken ensured the integrity of the study’s IMP through the use of customized packaging solutions, utilizing the fastest and most secure lanes possible to minimize waiting time, and offered detailed monitoring of shipments via Marken’s Global Control Center.

Advanced packaging solutions and the latest tracking and reporting technology ensured complete end to end visibility and security of the shipment through to the last mile.

As a result of Marken’s swift actions, the family seamlessly travelled to Pakistan for the holiday while still maintaining the child’s enrollment in a study for a rare, pediatric disease.

 

 

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