IN PARTNERSHIP Relabelling the clinical trial landscape
Digital Display Labels have the potential to be transformational within Clinical Trial supplies. T
he introduction of Digital Display Labels (DDLs) has the potential to significantly change the way that Investigational Medicinal Products
(IMPs) are both labelled and relabelled throughout the clinical trial lifecycle and supply chain. DDLs provide an innovative solution that will be transformational in terms of operational agility, optimising patient and clinical site use, and reducing costly returns and repackaging.
Understanding the cost of Re-anything The ability to extend the shelf life of IMPs, as stability data is established, is a significant challenge across studies within the Clinical Trial arena. The implications of having to recall drugs from clinical sites and performing the complex, costly, and time-consuming relabelling process has long been a focus area for improvement across the industry. From retrieving the product, removing it from its original packaging, and routing through the labour-intensive relabelling process whilst keeping aligned with all associated regulatory and quality protocols and documentation to reassign the IMPs, extending the expiration date within the Clinical Trial industry can carry significant costs. Outside of the financial burden, this process has the potential to negatively
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impact other key areas: Supply chain: In repackaging IMPs within the
relabelling process there is the potential for environmental conditions to be compromised during the cycle, with factors such as management of cold chain being a key consideration. Additional supply chain control steps may also then be required when transporting the IMP to the clinical site to ensure that the product is effectively controlled during the return process. Introducing error: Adding new or additional labels and removing tamper evident seals within the operational processes can then add further risk and potential for the label to be allocated incorrectly, with blinded studies at highest risk of error. Removing blinded study IMPs from their original packaging and allocating new kits elevates the potential for cross contamination, which demands increased process controls. Trial timelines: The logistics of this additional work extends the overall process time required to realign protocols and get the IMP back into circulation, thus extending the trial duration itself. Waste: Traditional relabelling can generate significant waste in materials, elongating the supply chain. It also requires significant labour and resources, and subsequently an increase in overall costs.
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