Rigorous clinical trials are the foundation of modern medicine. Before any new drug is approved by regulators, its makers have to prove the efficacy and safety of the product through carefully controlled tests on representative samples of patients.

Prior to sale, a new drug will undergo three or four phases of trials. These involve gradually increasing numbers of test subjects, from less than 100 in early tests to investigate the safety and efficacy of the product, to several thousand in "Phase 3 and 4" trials designed to confirm its safety and effectiveness in a diverse patient population.

Globally, the pharmaceutical industry spends around $40 billion a year on clinical trials, and the cost is rising by more than 5 percent a year. That's due to the increasing complexity of modern pharmaceuticals, the need to test with multiple patient groups in different parts of the world, and the difficulty involved in finding and recruiting participants for trials of drugs targeting rarer conditions. Companies have to get clinical trials right. There's a lot riding on them: the safety of trial participants, the treatment outcomes of future patients, and the $2.8 billion or so of investment required to identify, develop and prove a new drug.

Logistics are both a significant cost driver and a key pain point in all clinical trials. Running a trial requires the coordinated distribution and delivery of numerous items to multiple sites. That can involve everything from sensitive, high-value biopharmaceutical products that require specialized temperature-controlled transport, to computers, diagnostic equipment and clinical supplies. Today, those logistics activities are highly fragmented, involving multiple suppliers and service providers. Ensuring everything is in the right place at the right time ready for trial participants is difficult, time-consuming and error-prone. No wonder the top 20 global pharmaceutical companies spend around €2.6 billion ($3.2 billion) a year on research & development logistics.

Recognizing the challenges faced by the industry, a team at DHL's Start-up Lab is working on an innovative new approach designed to simplify and streamline the complete clinical trials logistics process, putting the patient first. DHL calls its new system iNebu. The name is inspired by biblical king Nebuchadnezzar, who presided over the first recorded "clinical trial" when asked to compare the effects of a 10-day diet of water and vegetables to his own richer fare of meat and wine.

"DHL understands how critical clinical trials are to the industry and recognizes that the logistics of managing a trial need to be improved," explains Claudia Roa, VP Life Science & Healthcare, Customer Solutions & Innovation Americas, DHL. "Our goal is to partner with our customers to improve the process for them, their investigational sites and other clinical trials stakeholders. By digitalizing our services, we can simplify the process and create better visibility for both inventory and shipments. In the end it's about ensuring delivery is done in a timely, compliant and cost-effective manner."

The project required some clever integration behind the scenes, linking DHL Global Forwarding's existing 21 CFR 11-compliant, cloud-based LifeTrack ecosystem with systems operated by DHL Express and DHL Supply Chain. It has a human element too, with control towers staffed by specialists in clinical trials logistics working to coordinate deliveries, and to handle problems and exceptions if they occur. All of this is largely invisible to the end user, however, who gains complete visibility of all shipments related to a specific trial or patient through a single interface or on a secure mobile app. iNebu is currently being used by two pilot customers and a wider rollout is planned for later in the year. — Jonathan Ward

Published: June 2018

Images: Lightfield Studios/Adobe Stock