CLINICAL SUPPLY MANAGEMENT ARTICLES
Managing Global Programs Across Multiple Stakeholders
Global programs succeed less on plans and more on alignment. Governance, communication, and early risk visibility drive execution across complex stakeholder networks today.
CLINICAL SUPPLY MANAGEMENT RESOURCES
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How to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how a risk-based approach can determine where a contingency plan is needed.
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Reliable clinical supply requires proper vendor selection, cross-functional communication, and safety nets built to accommodate an ever-changing geopolitical and global pharmaceutical landscape. To avoid supply disruptions for clinical drugs, sponsors must give clinical supply its proper weight in initial protocol development and trial design.
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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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Experts speak on supply capabilities within interactive response technology (IRT) – how flexibility is important to functionality and who to involve and which questions to ask in optimizing IRT for clinical supply.
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Randomization & trial supply management (RTSM) are critical functions of clinical trial IRT systems, supporting patient randomization plus managing drug inventory, site resupply, and participant dispensation.
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Sponsors are recognizing the potential benefits of decentralized clinical trials, including reduced operational costs and improved recruitment and retention of more diverse patient populations.
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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.