Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
- 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?
- Direct-To-Patient Trials Are Changing The Clinical Supply Chain
- When Clinical Supply Data Disagrees: Who Owns The Decision?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Vertex On Building Risk Into Manufacturing Network Strategy
Supply disruptions are becoming harder to predict. Explore practical strategies for continuity planning, supplier risk management, and network design to build lasting resilience.
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Inside A Gene Therapy Facility, Commercialization & Industrialization Project
An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases.
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Demonstrating The Value Of Investigational Drug Services Through Time-Based Metrics
Learn how adopting time-based metrics helps research teams accurately track workload, optimize staffing, and justify trial budgets.
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How Modern RTSM Platforms Are Eliminating Delays
Stop letting rigid legacy RTSM systems stall your clinical trials. Learn why manual change requests cause months of delays and how a modern, platform-based approach restores your study’s agility.
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RTSM Reusability: What It Is, Why Most Systems Lack It, And Why It Matters
Explore why RTSM should be viewed as a system for managing change. Learn how platform-based reusability reduces UAT churn, preserves institutional memory, and stabilizes mid-study amendments.
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The Crucial Role Of IRT/RTSM In Optimizing Drug Supply Budgets
Expand your knowledge of IRT/RTSM systems and their capabilities to tailor supplies to site-specific recruitment, significantly decrease drug waste and costs, ensure efficient IMP management, and more.
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Optimizing Clinical Trials In China With Strategic Solutions For Supply Chain
Plan proactively for clinical trials in China by aligning with National Medical Products Administration requirements and leveraging Free Trade Zones to streamline regulatory approvals and clinical supply importation.
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Revolutionizing Trial Supply Management With The Power Of Free Picking
Discover the power of SmartSignals RTSM’s new free picking feature, designed to revolutionize trial supply management by optimizing efficiency and reducing costs.
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Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization
While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
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What To Look For In Your IRT/RTSM Solution For A Simpler Trial Execution
Which factors should you consider when selecting an IRT/RTSM vendor to ensure your trial's randomization and supply management processes are successfully executed?
BEYOND THE HEADLINES
What happened. What it means for clinical supply.
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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.
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Lonza expands its accelerated DNA-to-IND pathway to complex biologics, targeting IND readiness in as little as six months and raising clinical supply planning considerations.
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.