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
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
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.
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
CLINICAL SUPPLY REGULATORY RESOURCES
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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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![Scientist research laboratory pipette GettyImages-487041629]( "Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions")
Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.
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![GettyImages-1189150676-Medicinal_Marijuana_Cannabis_ControlledSubstance]( "Controlled Substances In Clinical Trials")
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
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![Pharmaceutical-Drug-Manufacturing-GettyImages-1405788565]( "Specializing In Small And Early-Stage Partners, Not Just Small Batches")
Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.
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![electronic-medical-technology-GettyImages-1204743045]( "Benefits Of Electronic Labels: Investigational Medicinal Products")
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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![iStock-1209968955]( "Decentralized Clinical Trials: A Win For Patients, Sponsors, & Investigators")
Learn how the integral role of Direct-to-Patient Services plays a part in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.
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![GettyImages-1214112149-lab-team-collaboration-research]( "Creating Accurate, Efficient, And Effective CDMO Project Proposals")
To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.
