CLINICAL SUPPLY REGULATORY ARTICLES
Segregation Of Duties: Drug Accountability Needs Three Separate Roles
When one person orders, receives, and reconciles investigational product, a critical control disappears. See how role separation can strengthen drug accountability.
CLINICAL SUPPLY REGULATORY VIDEOS
Gain insights into managing global trial complexity, balancing accelerated timelines with compliance, using advanced technologies to improve efficiency, and leveraging partnerships to support seamless clinical operations.
Investigational products present a distinctly high-risk environment for labeling and barcoding. Explore best practices for barcoding solutions that allow for improved medication safety in clinical trials.
Understand state pharmacy regulations, prescription requirements, and operational considerations for shipping clinical supplies directly from pharmacies to patients' homes in decentralized trial models.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
CLINICAL SUPPLY REGULATORY RESOURCES
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![Vaccine injectable vials and syringe GettyImages-1252804942]( "Developing Injectable Drug Placebo Formulations For Clinical Trials")
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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![Marken-CEO Headshot C]( "Clinical Trial Logistics Provider Of The Year")
How can you utilize state-of-the-art GMP-compliant depot networks and logistics hubs to maintain product quality and safety standards for complex therapies?
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![iStock-1214764688-scientist-lab-analyze-research]( "Global Clinical Supply Solutions For Every Trial")
A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive strategy and manage day-to-day activities.
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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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![West_CZ Insert Needle 115860aw 11569_RGB_2]( "A Practical Packaging Components Checklist For Emerging Biotechs")
A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
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![pharma-manufacturing- GettyImages-2274021643]( "How Specialized CDMOs Help Advance Programs From Concept To Clinic")
Integrated drug development streamlines manufacturing, analytics, and supply to cut risk and speed timelines. Inhalation advances and flexible partnerships help therapies reach commercialization faster.
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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.
