Articles, App Notes, Case Studies, & White Papers
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Distributing Clinical Supply In The EU For Compassionate Use Programs
12/21/2022
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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Clinical Manufacturing: What It Is And How It Works
2/27/2022
Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?
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Avoiding The Risk Of A Non-Transparent Clinical Supply Solution
8/27/2021
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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Developing Injectable Drug Placebo Formulations For Clinical Trials
1/9/2024
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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Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain
With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.
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Gain Confidence In Clinical Trial Outcomes
Delve into the ways that smart packaging integrations within clinical trial strategies can improve adherence to dosing protocols and provide a comprehensive understanding of a patient’s exposure.
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GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm
8/15/2023
Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.
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Benefits Of Electronic Labels: Investigational Medicinal Products
12/2/2022
When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, learn why a label must be on its packaging that provides relevant and important information.
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Build A Foundation For Successful Clinical Manufacturing
5/8/2023
Establishing both the QTPP and CQA for your drug at the beginning of the product lifecycle is crucial for a successful GMP manufacturing process.
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Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours
3/1/2023
The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.