CLINICAL SUPPLY MANAGEMENT ARTICLES
Undocumented Changes Break Validated Clinical Systems
Small changes to IRT, EDC, and CTMS systems can quietly break validation. See why change control, testing, and documented approvals matter before deployment in a trial.
CLINICAL SUPPLY MANAGEMENT RESOURCES
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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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The pandemic created additional obstacles for the clinical supply chain. Ensuring continued clinical trial operation requires an optimal management solution for clinical material supply.
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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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Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.
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DtP trials are a win-win for patients and sponsors. The purpose of this white paper is to provide in-depth information on the various DtP approaches while offering insight into best practices when incorporating DtP into the protocol.
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Flexible clinical development requires scalable infrastructure, strong project management, and global logistics to ensure supply continuity and regulatory compliance.
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Explore how the optimization of Interactive Response Technologies (IRT) settings relieved the burden of managing global supply needs for a CRO customer and clinical sponsor.