The wrong regulatory filing sequence can close faster pathways, delay importation, and consume shelf life. Here’s how regulatory strategy can reshape clinical supply.
- CSM Feasibility Begins With Research Strategy And Study Design
- Clinical Supply Systems Need IT General Controls
- AI-Generated Data, Patent Protection, And The Implications For Clinical Supply
- The End Of Just-In-Time? Why Clinical Trial Supply Chains Are Rethinking Inventory Strategy
- Root Causes, Part 1: When Trial Design Locks In Supply Risk
- Last-Mile Lessons For Depot-To-Site Delivery
- Expanded Expertise, Deeper Insight: Clinical Supply Leader Welcomes Two New Advisors
- The Hidden Cost Of The "Cheap" Comparator Drug: Why The Lowest Price Can Become The Most Expensive Choice In Clinical Trials
ON-DEMAND WEBINARS
Understand state pharmacy regulations, prescription requirements, and operational considerations for shipping clinical supplies directly from pharmacies to patients' homes in decentralized trial models.
Gain expert insights on the future of RTSM strategy and its evolution with the changing clinical supply and technology landscape in our webinar.
This webinar will offer best practices for UAT for sponsor organizations with the aim of changing the conversations and expectations around the UAT process.
Explore best practices for comparator selection and supply optimization in clinical trials, including sourcing strategies, risk mitigation, regulatory compliance, and real-world cost-saving case studies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![clinical-trial-supply-challenges-GettyImages-2161372208]( "Managing Clinical Trial Supply Challenges In Complex Studies")
Managing Clinical Trial Supply Challenges In Complex StudiesComplex studies require flexible supply strategies that can adjust to shifting timelines, varied modalities, and global site needs. Adaptive, scalable planning helps lower risk.
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![iStock-1288879010-gloves-mask-box]( "5 Common Clinical Supply Chain Speedbumps")
5 Common Clinical Supply Chain SpeedbumpsClinical trials can be very complex. Discover the need to connect planning and oversight from sourcing to shipping, along with mastering requirements such as cold chain, border slowdowns, and data privacy.
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![Pharmaceutical-Drug-Manufacturing-GettyImages-1405788565]( "Specializing In Small And Early-Stage Partners, Not Just Small Batches")
Specializing In Small And Early-Stage Partners, Not Just Small BatchesMany small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.
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![pharma-success-GettyImages-2217587867]( "Why Advanced cGMP Manufacturing Is Key to Pharma Success")
Why Advanced cGMP Manufacturing Is Key to Pharma SuccessAdvanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.
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![ERP]( "How Pharmaceutical Manufacturers Can Take Control Of Their Supply Chain")
How Pharmaceutical Manufacturers Can Take Control Of Their Supply ChainIn an increasingly competitive and regulated landscape, the right ERP system is no longer optional—it’s essential to reclaim control and drive growth in pharmaceutical manufacturing.
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![GettyImages-1429005105-scientist-ipad-software-management]( "Choosing RTSM? Evaluate The Team Running It, Not Just The Software")
Choosing RTSM? Evaluate The Team Running It, Not Just The SoftwareHigh-performing RTSM requires more than just code. Discover why team continuity and clinical expertise are the most overlooked factors in reducing trial risk and ensuring regulatory compliance.
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![Machine Converyor With Glass Vials GettyImages-498492002]( "Building Robust Clinical Supply Chains To Support Global Trials")
Building Robust Clinical Supply Chains To Support Global TrialsEnsuring drugs reach patients at the right time and place is crucial. Review key areas to consider as you build a robust clinical supply chain that supports global trials effectively and efficiently.
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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-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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![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.
- 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
- Could Smarter Use of Clinical Supply Data Help Avoid Certain Protocol Amendments?
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.
