FDA staffing shortages and supply pressures are reshaping clinical trials, requiring closer coordination across regulatory, manufacturing, and operations.
- How Clinical Supply Teams Pull Better Demand Signals
- Why Clinical Supply Risk Starts With Demand Signals
- Clinical Supply Planning In A More Volatile And Regionalized World
- Navigating Brazil's Medical Device Clinical Trial Import Process
- Where Clinical Supply Chain Meets Humanity: Why It's Never "Just A Box"
- Managing Supply Chain Risk In Scale-Up And Multisite Trials
- Global Clinical Supply — Confronting Persistent Challenges With Strategic Action
- Digital Tools Are Failing Patients: 3 Ways Clinical Supply Can Protect Data Integrity
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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A Custom IRT System Facilitates Precision Medicine Studies
As the industry continues to embrace personalized medicine, the ability to implement and support an atypical supply chain is crucial.
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Safeguarding Cell Therapy Cryopreservation: Primary Containers
Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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Risk Mitigation In Direct-To-Patient Clinical Trials
The DTP model can help alleviate risks in patient enrollment (including diversity), retention, and adherence to study timelines and budgets. Explore how to ease trial troubles through DTP.
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Effective Use Of IRT In Decentralized And Hybrid Clinical Trials
Uncover the ways interactive response technologies are helping trial sponsors manage the distribution of medications, forecast trial supply, and integrate workflows with other technology platforms.
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Is Your Clinical Supply Strategy Ready For EU CTR?
One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging?
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Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch
Tech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.
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Quality Assured: Bringing Life-Changing Therapies To Patients
Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.
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What Are Decentralized Clinical Trials (DCTs)?
Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.
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Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
Learn 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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Transforming The Pharma Supply Chain
Start leveraging logistics partners with global end-to-end solutions that can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.
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.