A large pharmaceutical company was conducting multiple Phase II/ III trials in Brazil. Within the country, it was utilizing more than 40 investigational sites, handling primarily cold-chain shipments of biologics in insulated cold chain shippers designed to maintain 2-8°C for 48 hours.
The pharmaceutical companies had previously been managing multiple couriers within the country but was struggling with site complaints, temperature excursion issues and a burgeoning transportation budget. Specifically, the couriers utilized were:
- Failing to deliver the shipment to the authorized person at the site. As a result, shipments were either not delivered or the shipment was delivered to an unauthorized person and misplaced or mishandled.
- Delivering shipments outside of the investigational sites’ working hours, without notifying the site in advance or arranging for personnel to be available after hours. For investigational sites in cities at a significant distance from the depot, extensive temperature excursions were being documented when shipments were left at the facility outside of working hours, improperly stored or returned to the depot outside of the 48-hour window.
As a result, the sponsor was facing costly IMP wastage and rush shipment charges, while sites were burdened with patient rescheduling. Concerned that these issues would continue to negatively impact trials in Brazil, Fisher Clinical Services Brazil was brought in to manage in-country drug delivery.
Immediately, the Fisher Clinical Services Brazil team compiled a list of all sites and reached out to each one via phone in order to compile a list of critical site information, including authorized personnel names, working hours, and days/times available for shipment receipt.
With oversight of all Brazilian shipments, the Fisher Clinical Services Brazil Logistics Coordinators pre- scheduled 100% of site shipments by phoning each site in advance of every shipment. The project management team confirmed the sites’ availability to receive material on a specific date. While on the phone, they were able to review storage and delivery conditions as well as discuss any issues that the site may be experiencing. Sites were provided a contact name, phone number and email address in the event they experienced any issue. Since the Fisher Clinical Services team was in direct contact with the courier company, any site issue that arose was quickly resolved.
The local availability of Fisher Clinical Services staff, the proactive oversight of shipments and the active communication with in-country sites in their local language, eliminated the following courier issues and improved overall trial performance:
- Shipments arriving after a site closed or when no authorized personnel were available.
- Shipments delivered to unauthorized personnel
- Temperature Excursions as a result of improper storage or lack of timely receipt of material.
Pre-alert notifications to investigational sites in local languages, with track and trace capabilities and proactive management of couriers are available in countries across the globe through Fisher Clinical Services. Ask your account executive for more information.