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International Clinical Trials

The Complete Journey

Clinical trials are the most costly part of the pharmaceutical R&D sector, and are dependent on patients who are willing to participate. By streamlining study processes and developing a patient-centric approach, costs could be reduced, patient safety increased and data quality improved. The clinical trial supply chain contributes significantly to overall study expenses, but also bears great potential for optimisation by using the Internet of Things for data capture (1). To gain a better understanding of the supply chain, it is worth exploring the journey from the planning stage of clinical supplies to manufacturing, distribution and dispensing to patients.

Planning Supplies

Documentation is a key requirement in clinical trials. Although various data capture systems support the supply chain, these systems are not typically connected to each other, thus making manual processes and individual data entry necessary. Ultimately, all information for approval of a new pharmaceutical product is submitted electronically in one document. This creates an unusual situation, in which data are still recorded on paper documents but are also available online. Systems that capture and store these data include: software for demand planning; manufacturing systems; warehouse management systems; enterprise resource planning systems; clinical trial management systems (CTMS); and interactive response technologies (IRT, also known as interactive web response (IWR) or randomisation and trial supply management (RTSM)). These systems are normally used independently, and are only connected – if at all – when utilised within the same company.

A good example of this is the address of a clinical site pharmacy, which can often be found in the following locations: the CTMS, the warehouse management system of the central depot for the supplies, the carrier and IRT system. All of these systems receive the address via data upload – either from a list or by manual entry, both of which create the possibility of error.

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Andrea Zobel is Senior Director of Product Management, Clinical Trial Supplies and Logistics at PAREXEL. She has recently taken on the responsibility for the definition and implementation of new products and services in these departments. With a diploma in Biochemistry from the Freie Universität Berlin, Germany, and a PhD from the Max Planck Institute for Molecular Genetics, Germany, her scientific career includes 12 years of research in gene technology, pharmacology and preclinical development.
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