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International Clinical Trials

The Drivers of Success in Ancillary Supply Chain Management

Today’s pharmaceutical landscape relies increasingly on outsourcing efforts. Meanwhile, global rules, laws, and regulations continue to evolve at a rapid pace, and pressure to expedite market approvals for new drugs mounts. Due to the intertwined factors, a new, extremely complex global ‘ancillary’ supply chain has emerged. In this era of change, how does the ancillary supply chain respond to the needs of a rapidly changing industry and create better outcomes for drug discovery organisations and their patients?

The clinical trial ancillary supply chain (CTASC) – a global, extremely complex, highly variable, unregulated, and decentralised system – manages the flow of non-drug materials to sites for clinical investigator and patient use. Pharma organisations have elected to outsource requirements for ancillary supplies distribution (medical devices, laboratory equipment, patient supplies, etc.) to preferred partners that manage the chain via an integrated, end-to-end process. These preferred partners are staffed with medical professionals, as well as quality, regulatory, and supply chain experts, who conduct protocol and patient dosing schedule analyses, determine product selection based on trial specifications and country of use, review in-country regulatory and equipment licensure requirements, and source and procure supplies to arrive on site prior to first patient first visit (FPFV). A detailed supply plan is presented to the sponsor organisation prior to study kick-off, providing the roadmap by which the CTASC organisation will manage the flow of goods throughout the trial. In addition to the information noted above, the supply plan depicts the processes by which the CTASC will provide support for ongoing import and export regulatory analyses and control, inventory and depot management, estimated timelines for shipments on demand or in advance of patient arrivals, and reclamation and disposition processes for all supplies remaining at each site as the clinical trial closes. To achieve these goals in this highly complex market, CTASC organisations must utilise innovative technology, predictive analytics, and data mining to forecast demands, improve internal and external operations and deliverables, and drive value across the chain and throughout

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About the author

Dr Joanne Santomauro, CEO and Founder of Ancillare, LP, created the clinical and ancillary supply chain management industry in 2006. Prior to the company’s launch, pharma, biotechnology, contract, and medical research organisations had little transparency to the overall supply chain and had a limited grasp of the associated costs, processes, and regulatory and compliance requirements of this diverse global supply chain. Joanne’s 35 years of supply chain expertise led the company to launch its market-leading model.
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