Temperature excursions are inevitable. The real risk is the time lost deciding what to do. See how preplanned governance can turn long quarantines into routine events.
- The Silent Stockout: No One Owns The Data That Would Have Caught It
- Token Costs Will Decide Clinical Supply AI
- What Is "Demand" When There Are No Sales?
- The Reliance Trap: When Regulatory Strategy Becomes A Clinical Supply Problem
- Clinical Trial Supply Chains Are Entering The Era Of Predictive Risk Management
- Root Causes, Part 2: The Translation Problem Behind Clinical Trial Execution
- CSM Feasibility Begins With Research Strategy And Study Design
- Clinical Supply Systems Need IT General Controls
ON-DEMAND WEBINARS
Learn how leveraging a customs warehouse can streamline your supply chain, reduce VAT costs, and enhance global compliance and efficiency.
Individual data points over time can provide precise drug dosing histories that enable better understanding of protocol adherence, safety, efficacy, PK/PD and a drug’s exposure-response relationship.
Discover how flexible, site-focused monitoring strategies are transforming clinical trials by improving communication, enhancing compliance, and resolving challenges before they impact study success.
Join IRT industry veteran and drug supply expert Stefan Dürr for a discussion about how to reduce the impact of both traditional and emerging macroeconomic pressures on clinical trial supply.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![cell-gene-therapy-GettyImages-2157300524]( "FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study")
FastChain®: A Solution For Made-To-Order Gene Replacement Therapy StudyAdopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.
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![GettyImages-1163506017 labeling]( "IMP Labeling: EU CTR Transition Considerations")
IMP Labeling: EU CTR Transition ConsiderationsReview current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.
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![GettyImages-2189597043-production-facility-laptop-software]( "Why RTSM Software Doesn't Belong Inside An All-In-One Suite")
Why RTSM Software Doesn't Belong Inside An All-In-One SuiteDon’t let administrative convenience compromise study integrity. Discover why purpose-built RTSM is essential for managing the technical complexities and specialized demands of modern trials.
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![Refrigerated Container cold chain]( "Transportation Solutions For Cell And Gene Therapy Supply Chains")
Transportation Solutions For Cell And Gene Therapy Supply ChainsDeveloping a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.
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![GettyImages-1693748594 phone]( "RTSM: Randomization And Cohort Management, IP Inventory Management")
RTSM: Randomization And Cohort Management, IP Inventory ManagementSignant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
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![4_PharmaSource_Conference_CDMO Live copy]( "The Phase 2 Manufacturing Wall: The CMC Risk Hiding In Plain Sight")
The Phase 2 Manufacturing Wall: The CMC Risk Hiding In Plain SightHidden gaps in process maturity and organizational alignment can derail development. Discover how to identify risks early and improve readiness for key milestones.
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![Getty-1652511983-supply-chain-management]( "A Custom IRT System Facilitates Precision Medicine Studies")
A Custom IRT System Facilitates Precision Medicine StudiesAs the industry continues to embrace personalized medicine, the ability to implement and support an atypical supply chain is crucial.
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![iStock-635767756-clinical-trial-research]( "Building A Flexible, Challenge Resistant, Patient-Centric Clinical Supply Chain")
Building A Flexible, Challenge Resistant, Patient-Centric Clinical Supply ChainFlexible solutions, like demand-led supply and direct-to-patient distribution, are helping sponsors address the growing list of challenges presented by today’s increasingly complex studies.
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![West]( "Vial Containment Systems For Gene And Cell Therapies")
Vial Containment Systems For Gene And Cell TherapiesCZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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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")
Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And SolutionsExplore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.
- Root Causes, Part 3: The Hidden Cost of Clinical Supply Work That Doesn't Move Trials Forward
- Root Causes, Part 2: The Translation Problem Behind Clinical Trial Execution
- Root Causes, Part 1: When Trial Design Locks In Supply Risk
- Expanded Expertise, Deeper Insight: Clinical Supply Leader Welcomes Two New Advisors
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.
