Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
- The Hidden Work Between Protocol And Execution: Translating Requirements Into Supply Strategy
- Clinical Trial Supply In The EU And U.K.: A Regulatory Guide
- Clinical Supply Chains Need To Solve Problems Before They Happen
- How New Models Could Improve Trial Enrollment Forecasts
- Can Site Enrollment Data Improve Clinical Trial Forecasts?
- Can Standardizing Protocols Improve Clinical Supply Execution?
- Direct-To-Patient Trials Are Changing The Clinical Supply Chain
- When Clinical Supply Data Disagrees: Who Owns The Decision?
ON-DEMAND WEBINARS
Learn about strategies that can help build an understanding of risk assessment, in addition to how a study’s protocol requirements, packaging specifications, and more must be identified and addressed.
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.
Decentralized clinical trials are made up of a multitude of elements, from in home clinical capabilities, logistics, digital platforms, and technology, to global reach and more. This webinar shares important factors to consider to build your DCT ‘molecule’ successfully.
Learn how demand-led and hybrid clinical supply models reduce waste, accelerate timelines, and improve flexibility for global trials through regional hubs and patient-specific packaging strategies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Doctor Patient Engagement]( "Distributing Clinical Supply In The EU For Compassionate Use Programs")
Distributing Clinical Supply In The EU For Compassionate Use ProgramsExplore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.
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![deadlines time management-GettyImages-1350531674]( "How Modern RTSM Platforms Are Eliminating Delays")
How Modern RTSM Platforms Are Eliminating DelaysStop letting rigid legacy RTSM systems stall your clinical trials. Learn why manual change requests cause months of delays and how a modern, platform-based approach restores your study’s agility.
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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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![GettyImages-1288118586 cell development]( "Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials")
Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical TrialsLearn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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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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![Supply Chain - Getty- 1159559071]( "European Clinical Supply Planning – Balancing Cost, Flexibility, And Time")
European Clinical Supply Planning – Balancing Cost, Flexibility, And TimeBy evaluating the key parameters of a study, sponsors can identify the most effective location for packaging and distributing clinical trial supplies.
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![GettyImages-1254705026 clinical supplies]( "Using Tech Enabled Solutions To Boost Productivity And Sustainability")
Using Tech Enabled Solutions To Boost Productivity And SustainabilityHow can investing in suitable tech solutions enhance efficiency and reduce companies' carbon footprint?
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![03 West]( "Sample Sizes For Performance Testing Of Combination Products, Packaging")
Sample Sizes For Performance Testing Of Combination Products, PackagingWhen 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.
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![GettyImages-1086011250 logistics, supply chain]( "Decentralized Trials: The Value Of Direct-To-Patient, Pharmacy-Led Solutions")
Decentralized Trials: The Value Of Direct-To-Patient, Pharmacy-Led SolutionsPharmacy-led DTP models cut site burden, improve inventory control, and expand trial access. Learn how to optimize your decentralized trial supply chain for compliance and patient outcomes.
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![GettyImages-1616837193 coworkers tablet]( "How A Biotech Startup Transformed Its Clinical Trial Supply Management")
How A Biotech Startup Transformed Its Clinical Trial Supply ManagementDon’t let your trial get lost in the shuffle of legacy vendors. See how a high-touch, consultative approach can protect your study’s future.
BEYOND THE HEADLINES
What happened. What it means for clinical supply.
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![Black female doctor reviews medical record-GettyImages-2231130594]( "AstraZeneca And Oracle Explore AI To Improve Clinical Trial Recruitment")
AstraZeneca and Oracle are exploring AI for clinical trial recruitment, raising questions about how earlier enrollment insights could shape clinical supply forecasting and resupply plans.
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![science laboratory research, healthcare innovation, development, investigation-GettyImages-1751659695]( "Filament Health To Supply Psilocybin For Proposed Belgian Compassionate Use Program")
Filament Health will supply psilocybin for a proposed Belgian compassionate use program, pending regulatory approval and required authorizations for cross-border 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.
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.
