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
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Vial Containment Systems For Gene And Cell Therapies
CZ 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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Unblinding Risks In RTSM: What's Still Going Wrong, And How Korio Fixes It
Protecting 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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Why RTSM Software Doesn't Belong Inside An All-In-One Suite
Don’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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When Protocol Amendments Meet RTSM: From Headache To High-Performance
Learn why an RTSM solution should be adaptive and flexible, and should help clinical trial teams uncover the best ways to handle protocol amendments.
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The Dual Sourcing Approach
Having a secondary supplier in place for the manufacturing and packaging of life-saving critical medicines should be an essential part of your strategy in terms of patient health.
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Developmental Testing Of IV Solutions
As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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The Crucial Role Of IRT/RTSM In Optimizing Drug Supply Budgets
Expand your knowledge of IRT/RTSM systems and their capabilities to tailor supplies to site-specific recruitment, significantly decrease drug waste and costs, ensure efficient IMP management, and more.
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The Patient-Centric Clinical Supply Chain For Cell And Gene Therapies
This article explores how delivering cell and gene therapies to patients requires new levels of agility, flexibility and innovation in the logistical management of supply.
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Improving Site Efficiency With Automated Drug Resupply And Forecasting
Interactive Response Technology (IRT) can transform site operations by replacing error-prone manual processes with real-time, automated systems that relieve some of the burden on trial sites.
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A Smart Solution To Clinical Supply Management
Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.
- 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.