M11 may standardize protocol information, but as experts explain here, successful clinical supply execution depends on much more than what’s in the protocol.
- 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
- Undocumented Changes Break Validated Clinical Systems
- What Happens When The Clinical Forecast Changes?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The Critical Role Of Clinical Trial Packaging Services In Trial Success
Compliant, accurate packaging protects product integrity, supports dosing consistency, and keeps studies running smoothly. Smart components and controlled processes lower risk across complex trials.
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Controlled Substances In Clinical Trials
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
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Distributing Clinical Supply In The EU For Compassionate Use Programs
Explore 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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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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Key Considerations For Labeling Your Cell Or Gene Therapy
As 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.
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Level Up Your Supply Chain Initiatives
Shipping and storing advanced therapeutics are complex processes, but advancements in accountability, wearables, and technology capture real-time factors critical to safety and protocol.
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End-To-End Inventory Control Supports Biotech's Expanding Portfolio
Many organizations struggle with siloed operations, but this modern GxP inventory solution solves these challenges by providing a centralized, cloud-based platform for end-to-end visibility.
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Sample Sizes For Performance Testing Of Combination Products, Packaging
When 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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Finding The Optimal IRT/RTSM Design For Your Clinical Trial
Determine the best IRT/RTSM design for your trial through consideration of the user, data collection, and future-proofing.
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How Are You Labeling Your IP? Protect Your Clinical Trial With Distinct Treatment Numbers
Explore why engaging randomization and trial supply management (RTSM) services early in study startup can help protect clinical trials and expose substantial efficiencies, effectively baking in practices that help streamline supply chains.
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.