CLINICAL SUPPLY MANUFACTURING ARTICLES
Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.
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Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
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In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.
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Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.
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Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences.
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Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
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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.