New statistical and machine learning models could make clinical trial enrollment forecasts more adaptive, helping teams account for uncertainty and changing site performance.
- Direct-To-Patient Trials Are Changing The Clinical Supply Chain
- When Clinical Supply Data Disagrees: Who Owns The Decision?
- The Bullwhip Effect Hits Clinical Supply Chains
- Does Clinical Development Really Need An S&OP?
- What Your Tier 1 Supplier Map Might Be Missing
- Clinical Trial Supply Chains Need To Prepare For A Less Predictable World
- Root Causes, Part 5: The Structural Changes Clinical Supply Needs
- Rare Disease Trials: Execution Risks No One Warns You About
ON-DEMAND WEBINARS
Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.
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.
Join global logistics leaders for an in-depth analysis of the evolving pharmaceutical supply chain, exploring critical issues, emerging trends, and strategies for navigating the complexities of 2024.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-899483138 lab freeze cold 450x300.jpg]( "When Every Hour Counts: Emergency Transfer Protects Critical Biomedical Materials")
When Every Hour Counts: Emergency Transfer Protects Critical Biomedical MaterialsRapid deployment of specialized cold chain logistics and cryogenic assets ensures strict temperature compliance, protecting critical research continuity and preventing catastrophic material loss.
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![GettyImages-1398569507 regulatory]( "5 Ways To Get Ready For IRT Regulatory Inspections")
5 Ways To Get Ready For IRT Regulatory InspectionsPreparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.
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![supply chain checklist pharmaceuticals-GettyImages-1616023386]( "Unblinding Risks In RTSM: What's Still Going Wrong, And How Korio Fixes It")
Unblinding Risks In RTSM: What's Still Going Wrong, And How Korio Fixes ItProtecting study integrity requires more than just luck. Learn how systemic gaps lead to unintentional unblinding and how a proactive, engine-based approach can safeguard your clinical data.
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![Digital supply chain mangement, global logistic-GettyImages-2250495598]( "Trade Wars And Geopolitical Conflict: Navigating US Tariff Changes And The War In Iran")
Trade Wars And Geopolitical Conflict: Navigating US Tariff Changes And The War In IranTariffs and geopolitical disruptions are reshaping supply chains. Companies must act now to strengthen continuity planning, evaluate tariff recovery opportunities, and build more resilient logistics strategies for the future.
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![GettyImages-1346675584-team-lab-research-development]( "Key Considerations For Emerging Companies When Selecting Packaging Components")
Key Considerations For Emerging Companies When Selecting Packaging ComponentsRecognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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![GettyImages-2036497889-lab-computer-research]( "RTSM Reusability: What It Is, Why Most Systems Lack It, And Why It Matters")
RTSM Reusability: What It Is, Why Most Systems Lack It, And Why It MattersExplore why RTSM should be viewed as a system for managing change. Learn how platform-based reusability reduces UAT churn, preserves institutional memory, and stabilizes mid-study amendments.
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![GettyImages-1404941712-Capsules_Blister_Packaging]( "Gain Confidence In Clinical Trial Outcomes")
Gain Confidence In Clinical Trial OutcomesDelve into the ways that smart packaging integrations within clinical trial strategies can improve adherence to dosing protocols and provide a comprehensive understanding of a patient’s exposure.
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![GettyImages-1002000796-lab-research-scientist-development]( "Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials")
Functional Testing Summary Of Daikyo Crystal Zenith Nested VialsThe Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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![Getty-1652511983-supply-chain-management]( "The Tale Of Two Clinical Supply Chains: The Risks Of Fragmented Systems")
The Tale Of Two Clinical Supply Chains: The Risks Of Fragmented SystemsHere we examine two contrasting approaches to showcase how a centralized inventory management system is an effective tool for supporting a robust supply chain.
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![iStock-1276580570-cryopreservation]( "Key Considerations For Labeling Your Cell Or Gene Therapy")
Key Considerations For Labeling Your Cell Or Gene TherapyAs sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.
BEYOND THE HEADLINES
What happened. What it means for clinical supply.
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![medical lab technicians Working Together-GettyImages-2187044930]( "Prelude Therapeutics And Lilly Agree To Supply Drugs For Combination Trial")
Prelude Therapeutics and Lilly agree to supply two medicines for a Phase 1 breast cancer trial, highlighting coordination needs as the study advances to combination cohorts.
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![biopharmaceutical drug manufacturing, bioreactor facility-GettyImages-2281747941]( "Lonza Expands DNA-To-IND Pathway For Complex Biologics")
Lonza expands its accelerated DNA-to-IND pathway to complex biologics, targeting IND readiness in as little as six months and raising clinical supply planning considerations.
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![shipping temperature controlled-GettyImages-1387193042]( "FedEx Europe Launches Digital Portal For Temperature-Controlled Pharmaceutical Shipments")
FedEx launches a digital booking portal across 26 European markets for temperature-controlled pharmaceutical shipments, packaging orders, scheduling, and returns.
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![Drug manufacturing - pharmaceutical industry-GettyImages-1405788998]( "Andelyn Biosciences And PQP Group Establish EU And UK Supply Pathway For Cell And Gene Therapies")
Andelyn Biosciences and PQP Group partner to coordinate import, QP certification, and distribution for cell and gene therapies entering European clinical supply markets.
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![FDA Headquarters-GettyImages-1286971245]( "FDA Transparency Roadmap Could Give Clinical Supply Teams More Visibility")
FDA transparency efforts could give clinical supply teams more insight into regulatory and inspection risks that may affect manufacturing, inventory and distribution.
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.
