Contributed Commentary by Patty Murdock 

July 16, 2021 | From two-hour grocery delivery to telehealth visits, people have come to expect convenience, immediacy, and personalization from a wide range of everyday service providers. Clinical trial patients are no exception. The clinical trial world has seen a dramatic increase in decentralized clinical trials (DCTs) over the past year—along with the demands of their increased complexity and patient-centric focus.

A supply chain strategy that truly puts patients at the center requires a wide variety of trial services, delivered seamlessly. Improved patient access, reliability, customizability—all these things are incompatible with fragmented service and require the central coordination and end-to-end oversight only available from a comprehensive, single-source solutions provider.

The Patient-Centric Supply Chain Ecosystem

Patient-centric clinical trials demand a wide range of interoperable services and supplies including, but not limited to:

• Global GMP depot network: a global, interconnected network extensive enough to provide localized storage and distribution needs
• Patient-centric kit services: a network of assembly locations that provides consistent quality, with the ability to implement flexible, scalable solutions
• Biological sample shipments: a global system specifically designed for time- and temperature-sensitive biological sample shipments, full oversight and chain-of-custody of materials
• Transport solutions: the breadth of global reach and the depth of local/alternative, specialty transport solutions
• Direct-to-Patient/Direct-From-Patient service: the ability to deliver clinical trial materials and retrieve biological samples directly to and from a patient’s location, with full temperature monitoring, quality controls and audit trail from pickup to delivery
• Home healthcare services: an extensive network of local nursing providers who are qualified to conduct a variety of protocol procedures in the patient’s home (e.g., IV, sample retrieval, EKG/ECG and assessments)

Because supply chain services have so much overlap, imagine the complexity of managing multiple factors within the process, across multiple vendors. Factor in the increased flexibility and agility necessitated by patient-centric trials, and the likelihood of communication and coordination errors—not to mention administrative burden—increases dramatically. So, what is the answer?

A Single-Source, End-to-End Partner: Nothing Slips Through the Cracks

For increasingly patient-centric approaches like DCTs, outsourcing with a single end-to-end partner reduces risk by consolidating accountability and all functions under one organization that can control and coordinate all facets with greater visibility. Clients don’t have to interface with different vendors for individual services and worry about whether those different vendors will manage to coordinate with each other. An all-encompassing supply chain partner can ensure efficiency and quality because they manage all activities in all stages of the supply chain ecosystem.

The benefits are numerous. One partner creates efficiencies through a single point of contact, unified invoicing and consistent processes that yield both time and operational cost savings. When patient centricity is the goal, timeliness and agility are critical—and most seamlessly delivered from a single company, as opposed to several disconnected ones.

Real Life Case Study: Full-Service Agility and Patient-Centricity

In this recent example, a sponsor had an immunocompromised U.S. citizen stranded in South Africa in need of a study drug, which was not available in-country. Delivery was further complicated because multiple regulatory bodies were closed due to COVID-19. It was necessary to clear multiple, complex regulatory and transportation hurdles and quickly deliver the required medication before it ran out, to continue treatment and keep the patient enrolled in the trial. This meant engaging help from the U.S. State Department and Embassy in South Africa, maintaining one point of constant communication with the sponsor, site and internal teams while maintaining full compliance with privacy laws. 

The supply chain partner needed to be agile to react quickly. Global regulatory expertise was required, and those regulatory answers needed to be translated into a transportation solution. Without a single-source provider that could manage all these aspects, the burden would have landed with the sponsor and communication between all parties would likely have suffered. 

Ultimately, the patient received their clinical drug supply for the duration of their stay in South Africa, avoiding any disruptions to their treatment, or their trial enrollment and status. A single-source partner, with end-to-end capabilities, not only made the outcome optimal, but likely presented the only chance that it could happen at all. 

A Complete End-to-End Ecosystem of Services Enables the Ultimate Patient-Centric Supply Chain

As seen in theory and made evident in practice, there’s immense value working with one comprehensive partner that can manage the entire clinical trial supply chain. They deliver a breadth of services and access to networks that can store, transport, deliver and gather materials and data directly to and from patients. They offer global expertise that can navigate complex regulatory challenges and craft agile solutions with unified processes and technology that enable it all to run smoothly. As we work to deliver convenience, immediacy and personalization through patient-centric clinical trials, a single, comprehensive end-to-end provider possesses the scope, agility, efficiencies, coordination and expertise required to deliver.

Patty Murdock, Marken’s Senior Director of Global Patient Centric Services and Project Management, has 16 years industry experience including packaging/labeling, global distribution, IRT, Direct-to-Patient (DTP), and Direct-from-Patient (DFP). Patty has managed many mega trials for DTP/DFP in the past 5 years since joining Marken. She can be reached at patty.murdock@marken.com.