FDA demographic mandates can upend global trial supply, stranding inventory, driving panic packaging, and creating hidden bias that undermines study execution.
- At The Point Of Review: How Clinical Shipments Are Evaluated In Practice
- The cGMP Reality Of Clinical Supply For Advanced Therapies
- How Exit Strategy Should Shape Clinical Trial Supply Planning
- This Assumption Will Break Your Clinical Trial
- When Clinical Supply Fails, Small Biotech Trials Stall
- Putting Vaccine Supply Resilience To The Test: The Last Mile
- How Clinical Supply Drives Resilience In Global Vaccine Networks
- From Inconsistency To Structure: A Model For Defensible Compliance Decisions
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Navigate Complex Ancillary Supply Sourcing Challenges
Explore the evolvement of the clinical trial landscape over recent years, as well as the new challenges that this poses for the clinical supply chain.
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IMP Labeling: EU CTR Transition Considerations
Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.
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Global Clinical Supply Solutions For Every Trial
A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive strategy and manage day-to-day activities.
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Managing Clinical Trial Supply Challenges In Complex Studies
Complex 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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Optimizing IRT For Clinical Supply Management
Experts speak on supply capabilities within interactive response technology (IRT) – how flexibility is important to functionality and who to involve and which questions to ask in optimizing IRT for clinical supply.
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Creating Accurate, Efficient, And Effective CDMO Project Proposals
To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.
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Advantages Of Robotic Aseptic Processing
Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
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Logistics In Cell Therapy: Reducing Workflow Risk
Explore key steps that should be taken when executing a cell therapy clinical trial, from selecting the right sites to optimizing study retention.
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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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Emerging Biopharm Rapidly Sets Up Phase 1 Oncology Trial
Uncover how an emerging biopharmaceutical company was able to expedite the initiation of a Phase 1 oncology trial for a novel treatment targeting relapsed/refractory multiple myeloma.
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.