CLINICAL SUPPLY REGULATORY ARTICLES
Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide
ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders.
CLINICAL SUPPLY REGULATORY VIDEOS
Decentralized clinical trials are made up of a multitude of elements, from in home clinical capabilities, logistics, digital platforms, and technology, to global reach and more. This webinar shares important factors to consider to build your DCT ‘molecule’ successfully.
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
Clinical supply innovators from across the industry share their experiences and lessons learned as they work to normalize the use of adherence measurement tools and smart medicine packages.
This webinar aims to introduce the main regulatory themes, as well as provide a practical insight into converting regulatory theory to practical steps to enable DtP on global studies.
CLINICAL SUPPLY REGULATORY RESOURCES
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![iStock-1088247762-risk]( "Avoiding The Risk Of A Non-Transparent Clinical Supply Solution")
With the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.
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![GettyImages-1163506017 labeling]( "IQVIA Labeling Compliance Solutions")
Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.
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![GettyImages-1288438537 ecosystem]( "Clinical Research As A Delicate Ecosystem")
Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.
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![Quality Management GettyImages-1336716297]( "Quality Assured: Bringing Life-Changing Therapies To Patients")
Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.
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![GettyImages-1327568875-technology-clinical trials-computer-medicine-research]( "A Smart Solution To Clinical Supply Management")
Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.
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![Doctor Patient Engagement]( "Distributing Clinical Supply In The EU For Compassionate Use Programs")
Explore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.
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![GettyImages-820427458 clinical trials]( "Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide")
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.
