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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Accelerating A Complex Global Cardiovascular Outcomes Trial Via Coordinated Execution
Coordinating CRO, clinical supply, and central lab activities from the start shaped how a 1,500-site, 35-country cardiovascular outcomes trial moved ahead of plan on activation and enrollment.
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How Life Sciences Leaders Are Preparing For More Curveballs In 2026
Anticipate regulatory shifts and supply chain hurdles with agile scenario planning. Move beyond fragmented systems to build a resilient, data-driven foundation for a volatile industry landscape.
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Improving Clinical Trial Label Translation Through Centralized Reuse And Control
Eliminate workflow inefficiencies and regulatory risk in global trials with a centralized translation framework and validated phrase library for consistent, cost-effective execution.
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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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Precision and Compliance in Pharmaceutical Packaging
Reliable, compliant packaging preserves product integrity, supports regulatory readiness, and lowers risk. Careful components and controlled processes keep complex therapies protected.
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Specializing In Small And Early-Stage Partners, Not Just Small Batches
Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.
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Treating Deficiencies In Employee Training And Mentorship
Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.
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Turning Rapid Study Start-Up Into Enrollment Momentum
A large Phase III ATTR-CM outcomes trial spanning 37 countries reached 50% enrollment eight months early, with monthly accrual rates running 3–5x above plan through coordinated cross-functional execution.
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How To Build Effective Clinical Trial Oversight And Leadership
In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.
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Overcome The Supply Chain Complexities Of Vaccine Development
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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.