CLINICAL SUPPLY LOGISTIC ARTICLES
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A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.
CLINICAL SUPPLY LOGISTIC RESOURCES
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The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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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.
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Data is the single most important thing in a clinical trial. Leverage the power of clinical trial data with effective utilization and access in a changing regulatory landscape.
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A Japan-based biotechnology company leveraged Signant SmartSignals® GxP Inventory, which improved visibility, reduced risks and costs, and optimized operations in this case study.
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Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
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Looking ahead, the evolution of RTSM in clinical trials points towards cloud-based solutions, heightened emphasis on patient safety, and greater collaboration among stakeholders. Learn how you can prepare.