Logistics providers must have extremely flexible global networks, highly trained personnel, supporting technology and extensive regulatory expertise to offer efficient, compliant and cost-effective services.
Patient centricity, complex regulations and the need for cost minimisation
As the pharmaceutical industry has evolved, the nature of clinical trials has changed. Evidence-based medicine, a patient-centric industry focus, the increased development of orphan drug candidates and the promise of next-generation patient-specific cell and gene therapies are all driving the growth of direct-to-patient sample delivery and pick-up.
Not only has the number of clinical trials increased dramatically in recent years — 33-fold since 2000, according to the National Institutes of Health — they are more complex.1 Global, multi-site studies with locations in numerous remote locations are common, particularly for orphan drugs. Trials are lasting longer to demonstrate enhanced efficacy compared with existing products and long-term safety for treatments targeting chronic diseases.2 Complicated dosing schedules, the use of adaptive trial designs and the growing percentage of temperature-sensitive biologic drugs further contribute to trial complexity.3
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