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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Here we examine two contrasting approaches to showcase how a centralized inventory management system is an effective tool for supporting a robust supply chain.
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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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Drive excellence in clinical trials by utilizing forecasting to better plan clinical supply budgets and project timelines, and identify potential supply-related issues before they negatively impact a study.
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Shipping and storing advanced therapeutics are complex processes, but advancements in accountability, wearables, and technology capture real-time factors critical to safety and protocol.
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While RTSM systems help reduce many of the risks in clinical trials, each trial’s unique setup necessitates a risk analysis to identify trial-specific challenges.
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During clinical trials, the intricacies of financial management intensify, necessitating advanced ERP functionalities to handle clinical accruals, compliance, and reporting.
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As the industry continues to embrace personalized medicine, the ability to implement and support an atypical supply chain is crucial.