CLINICAL SUPPLY REGULATORY ARTICLES
What Clinical Trial Supply Teams Actually Need From CQV Before Batch Release
Batch release delays rarely start in QA. Learn how CQV, digital integrity, risk-based validation, and global compliance keep clinical supplies moving.
CLINICAL SUPPLY REGULATORY RESOURCES
-
Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.
-
Analyze the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency, and accelerate speed to market.
-
The right comparator sourcing strategy is critical. Review what sponsors need to consider when selecting the right provider in order to source the needed commercial products.
-
Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.
-
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.
-
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?
-
To make the best use of artificial intelligence (AI), drug sponsors need to understand where health authorities are drawing the lines.