CLINICAL SUPPLY REGULATORY ARTICLES
4 Tips For Successful Collaboration With Your EU Qualified Person
Engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated challenges.
CLINICAL SUPPLY REGULATORY VIDEOS
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
Achieving supply chain resilience is crucial, and flexible distribution strategies and ready-to-use depot and logistics networks are instrumental in establishing limitless flexibility and expertise capable of identifying possible risks.
CLINICAL SUPPLY REGULATORY RESOURCES
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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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![GettyImages-1333159166-cold-chain-shipping-logistics-transportation]( "Transforming The Pharma Supply Chain")
Start leveraging logistics partners with global end-to-end solutions that can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.
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![GettyImages-1333159166-cold-chain-shipping-logistics-transportation]( "Overcoming Obstacles To Deliver Critical Autologous Cell Therapy")
See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Advantages Of Robotic Aseptic Processing")
Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
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![audit management]( "Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio")
Learn how the CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study that needed to pivot to a decentralized protocol during the pandemic or face trial disruption.
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![GettyImages-1413600685-lab-team-collaboration-computer-research]( "Reaching First-In-Human Trials Faster: Connect With The Right Partner")
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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![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.
