CLINICAL SUPPLY REGULATORY ARTICLES
Managing Customs, Import/Export Requirements, And Cross-Border Logistics Challenges
Customs delays can derail clinical trials in days. Learn practical strategies for import compliance, digital preclearance, and resilient cross-border logistics.
CLINICAL SUPPLY REGULATORY VIDEOS
This presentation explores practical pharmacy considerations in early-phase clinical trials, offering real-world insights from experienced clinical research pharmacists.
Choosing the right clinical packaging and supply chain partner to support APAC studies can vary significantly based upon which countries are involved and the types of services required.
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.
In this presentation, you’ll get recommendations to help you stay inspection-ready and learn about the importance of clear roles, audit trails, data integrity, and training.
CLINICAL SUPPLY REGULATORY RESOURCES
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![GettyImages-1751848523-meeting-evaluation-charts-table]( "Writing Effective Clinical Regulatory Documents For Therapy Trials")
Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.
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![Medical-Research-laborratory-GettyImages-1354172439]( "Investigational Medicinal Products: Labeling Changes And Their Implications")
Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.
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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-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.
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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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![GettyImages-1294339697-computer-monitor-test-research-controls]( "Master Protocol Studies: Technology Considerations For The 'Never Ending' Clinical Trial")
Since the FDA is now encouraging creativity in trial designs, it is important for all stakeholders to adapt processes to follow the science and ultimately bring medicines to patients, faster. This white paper addresses the complexities that come with these trial designs, and how randomization and trial supply management (RTSM) solutions are critical to run flexible, robust, and quality-driven trials.
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![03 West]( "Sample Sizes For Performance Testing Of Combination Products, Packaging")
When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
