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.