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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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.
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Clinical Manufacturing: What It Is And How It Works
Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?
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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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Outgrowing Excel: Implementing RTSM In A Live Phase I Trial
Learn how a clinical-stage oncology biotech successfully transitioned a live Phase I trial from manual spreadsheets to RTSM without disrupting site momentum or patient enrollment.
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Outsourcing Your Highly Potent Oncology Drug Product
Precision oncology treatments require specialized manufacturing and packaging, leading companies to outsource production. Assessing a CDMO’s highly potent processing capabilities is critical.
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The Phase 2 Manufacturing Wall: The CMC Risk Hiding In Plain Sight
Hidden gaps in process maturity and organizational alignment can derail development. Discover how to identify risks early and improve readiness for key milestones.
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Vial Containment Systems For Gene And Cell Therapies
CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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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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Key Considerations For Packaging Solutions For Cell And Gene Therapies
Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.
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Increasing Efficiency And Reducing Drug Waste
Discover how streamlined clinical supply chain management helped accelerate study timelines, reduce costs, and support global treatment delivery through a strategic technology partnership.
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.