CLINICAL SUPPLY PACKAGING ARTICLES
The New Clinical Packaging Paradigm: Differentiation And Decentralization
The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?
CLINICAL SUPPLY PACKAGING RESOURCES
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Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.
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Explore why engaging randomization and trial supply management (RTSM) services early in study startup can help protect clinical trials and expose substantial efficiencies, effectively baking in practices that help streamline supply chains.
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Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.
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Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
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A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
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When selecting a supply chain partner, due diligence is critical. This article highlights questions you should be asking to ensure you are selecting the right supply chain partner for your clinical trial needs.
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Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.