In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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ON-DEMAND WEBINARS
Explore the opportunities to optimize your supply chain strategy and facilitate direct-to-site, direct-to-patient and hybrid services utilizing a global GMP depot network.
This webinar discusses the types of master protocols and how configurable, modern RTSM systems enable fast and seamless mid-study changes to help you efficiently run your master protocol study.
This webinar presents the ultimate guide to scenario planning through modern technology as a way to inform clinical supply decisions.
Watch as industry experts explore the advancements in drug accountability facilitated through IRT, encompassing innovative methods for managing site variations and sustainable supply chains.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1296498102 lab technician]( "Clinical Supply Optimization: Process Improvement Accelerates Trials")
Clinical Supply Optimization: Process Improvement Accelerates TrialsA biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.
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![GettyImages-1254705026 clinical supplies]( "A Supply Chain Management Solution Designed for Clinical Research")
A Supply Chain Management Solution Designed for Clinical ResearchIn this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.
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![GettyImages-1180780708 health]( "Benefits Of Implementing EDC & Medical Coding With RTSM")
Benefits Of Implementing EDC & Medical Coding With RTSMDiscover what happened when the Fountayn Platform, including RTSM, was used to support a client’s two-year, Phase III study seeking a cure for multiple sclerosis.
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![Thinking Outside Of The Freezer: DNA And RNA Storage]( "Thinking Outside Of The Freezer: DNA And RNA Storage")
Thinking Outside Of The Freezer: DNA And RNA StorageWhile ultra-low temperatures are the current state-of-the-art solution for biospecimen storage, ambient storage is an interesting option and could be superior in certain limited situations. For many types of samples, it’s possible that we will always have to use ultra-low temperatures for long-term storage. For other sample types, such as DNA and RNA, there are alternative solutions.
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![gettyimages-946264212-170667a]( "Navigate Complex Ancillary Supply Sourcing Challenges")
Navigate Complex Ancillary Supply Sourcing ChallengesExplore the evolvement of the clinical trial landscape over recent years, as well as the new challenges that this poses for the clinical supply chain.
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![GettyImages-1293772957-scientist-laboratory-computer-drug-development]( "Five Key Trends In CMC")
Five Key Trends In CMCCMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.
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![GettyImages-1344606074 data insights]( "Data-Driven Adaptive Trials Enhance Safety, Progress, And Economics")
Data-Driven Adaptive Trials Enhance Safety, Progress, And EconomicsBy offering guidance on optimizing ROI from extensive data collections and various endpoints in clinical studies, learn how IRT technology can enhance the data-driven approach for sponsors.
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![GettyImages-1354932664 tech provider]( "Considerations When Selecting An Interactive Response Technology Provider")
Considerations When Selecting An Interactive Response Technology ProviderInteractive response technology (IRT) systems ensure clinical trial participants receive the correct treatment, facilitate enhanced logistics tracking, and empower users to obtain real-time data.
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![iStock-1002126898-graph-tablet-meeting-risks-planning]( "Critical Requirements In Sourcing Comparator Drugs")
Critical Requirements In Sourcing Comparator DrugsSourcing comparator drugs has become complex in the clinical supply chain. As a result, clinical trial sponsors and pharma companies are eager to identify opportunities to overcome these challenges.
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![GettyImages-1266357505-vaccine-development-lab]( "How To Evaluate A Clinical Supply Chain Partner To Meet Vaccine Trial Needs")
How To Evaluate A Clinical Supply Chain Partner To Meet Vaccine Trial NeedsWhen selecting a supply chain partner, due diligence is critical. This article highlights questions you should be asking to ensure you are selecting the right supply chain partner for your clinical trial needs.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.
