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Why a comprehensive sourcing strategy underpinned by clinical supply chain experience is critical.
November 14, 2023
By: Ed Lewis,
Carol Alexandre, Vice President, Clinical Trial Supplies, IQVIA
With outsourcing being an accepted and integral practice in clinical research, pharmaceutical and biotechnology companies look to contract research organizations (CROs) to help them achieve critical time and cost savings in the eternal race to get product to market quickly and without compromising quality. The needs of clinical trial sponsors can be complex and differ greatly but regardless of their size, location or therapeutic focuses, there is a universal need for qualified partners who can collaborate with flexibility and solve problems through experience and innovation. One common problem revolves around sourcing comparators for use in clinical trials. Comparators are reference treatments used for comparison alongside investigational products. Comparator treatments are typically the gold standard against which an IP is measured and are increasingly being used in trials. According to a global market study published in May 2023, comparator sourcing is expected to increase from $974 million in 2022 to more than $1.3 billion by 2031.1 Comparators can be a critical part of a trial, but their use requires specific expertise to navigate supply nuances and potential pitfalls. To properly evaluate the IP against treatment that may be the standard of care, a comprehensive supply strategy is needed. First, the sponsor needs to select the comparator or reference drug to use, and second, must source and provide it to every trial site without disruption while maintaining regulatory compliance. CROs typically assign a dedicated supply chain group to studies, which helps ensure that the end-to-end supply process is efficiently conducted without compromising data or quality or significantly adding to trial costs. Given the multiple layers of operational considerations within the procurement process, close collaboration between trial sponsors and partners is integral to a procurement strategy with contingency scenarios to ensure trials are executed as planned. Because industry interest in comparator integration, notable components of a strong comparator procurement strategy are discussed below.
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