CLINICAL SUPPLY LOGISTIC ARTICLES
How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO of his eponymous consulting company. His response did not disappoint.
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.