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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Planning Your Packaging For A Seamless Transition From Clinic To Launch
Explore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.
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IRT: A New Approach To Meeting The Needs Of Early Phase Trials
As early phase clinical trials become more sophisticated, sponsors are now leveraging flexible IRT solutions to replace error-prone manual processes and gain greater control and efficiency.
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CDMO Support: Success In Early-Phase Drug Product Development
As sponsors strive to deliver therapies with increasing efficiency, CDMOs are poised to remain vital, offering specialized expertise, accelerated timelines, cost efficiency, and risk mitigation.
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Automation Testing In RTSM Software: What Is It And What's The Impact
Move beyond the limitations of manual oversight to see how automated frameworks ensure precision, speed, and reliability for the most sophisticated and adaptive clinical trial designs.
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A Guide To RTSM For Clinical Trials
Looking ahead, the evolution of RTSM in clinical trials points towards cloud-based solutions, heightened emphasis on patient safety, and greater collaboration among stakeholders. Learn how you can prepare.
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Creating A Sustainable Pharmaceutical Supply Chain
Learn how CDMOs can drive transformation in the supply chain and create a more sustainable future for the pharmaceutical manufacturing industry.
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Using Tech Enabled Solutions To Boost Productivity And Sustainability
How can investing in suitable tech solutions enhance efficiency and reduce companies' carbon footprint?
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Ensuring On-Time Release Of CAR-T Cell Treatment In Spain
Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.
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Delivering Apheresis Treatment From The USA To The UK Within 24 Hours
The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.
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Key Considerations For Emerging Companies When Selecting Packaging Components
Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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.