Clinical trial policy is shifting research closer to patients, creating new demands for forecasting, distribution, inventory, accountability, cold chain, and cross-functional planning.
- Why Shelf Life Should Shape Global Country Activation
- Three Months Too Late: How Late Decisions Create Clinical Supply Challenges
- The Hidden Work Between Protocol And Execution: Translating Requirements Into Supply Strategy
- Clinical Trial Supply In The EU And U.K.: A Regulatory Guide
- Clinical Supply Chains Need To Solve Problems Before They Happen
- How New Models Could Improve Trial Enrollment Forecasts
- Can Site Enrollment Data Improve Clinical Trial Forecasts?
- Can Standardizing Protocols Improve Clinical Supply Execution?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Hidden Benefits Of Clinical Forecasting & Supply Planning Solutions
Streamline clinical supply chain management with SmartSignals Supplies, reducing errors and inefficiencies from spreadsheet-based forecasting.
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Lifecycle Planning For Containment And Delivery Of Biologics Drug Products
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.
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Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage
Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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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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Overcoming Challenges In Cell And Gene Therapy Containment
Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.
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Prefillable Syringe Plungers: A Solution For Low Temperature Storage
Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.
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Advantages Of Sourcing Biosimilars Vs. Branded Biologics In Clinical Trials
Evaluate biosimilar alternatives during clinical trial planning to reduce comparator drug costs and improve overall study efficiency without compromising trial integrity.
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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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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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How Clinical Trial Complexity Impacts End Users
This article examines clinical trial complexity through the lens of study investigators, site staff, CRAs, sponsor study and supply managers, and how the RTSM/ IRT provides the ability to be as creative as needed.
BEYOND THE HEADLINES
What happened. What it means for clinical supply.
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Medicine labeled for clinical trials reached children receiving routine SMA treatment in Kerala, raising questions about inventory controls, labeling and supply authorization.
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Syneos Health and Optum are developing adaptive clinical trial planning capabilities that could help sponsors anticipate protocol changes and supply risks earlier.
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AstraZeneca and Oracle are exploring AI for clinical trial recruitment, raising questions about how earlier enrollment insights could shape clinical supply forecasting and resupply plans.
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Filament Health will supply psilocybin for a proposed Belgian compassionate use program, pending regulatory approval and required authorizations for cross-border supply.
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Prelude Therapeutics and Lilly agree to supply two medicines for a Phase 1 breast cancer trial, highlighting coordination needs as the study advances to combination cohorts.
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.