CLINICAL SUPPLY MANAGEMENT ARTICLES
Does Clinical Development Really Need An S&OP?
Clinical supply S&OP can align demand, CDMO capacity, inventory and program trade-offs, but central planning and a clinical-focused D&OP model may work better.
CLINICAL SUPPLY MANAGEMENT RESOURCES
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Since the FDA is now encouraging creativity in trial designs, it is important for all stakeholders to adapt processes to follow the science and ultimately bring medicines to patients, faster. This white paper addresses the complexities that come with these trial designs, and how randomization and trial supply management (RTSM) solutions are critical to run flexible, robust, and quality-driven trials.
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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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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.
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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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An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases.
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Rachel Curran, Head of Sourcing Services and Special Accounts, discusses the requirements, challenges, and solutions to comparator and co-therapy drug sourcing for clinical trials.
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During clinical trials, the intricacies of financial management intensify, necessitating advanced ERP functionalities to handle clinical accruals, compliance, and reporting.