Temperature-sensitive drugs demand a cold chain that predicts disruptions, manages risks, and coordinates globally to keep trials on time and patients safe.
- 6 Risks To Clinical Supply Spurred By 'Once In A Lifetime' Lp(a) Screening
- Where Trial Budgets And Supply Plans Go Off Track — Earlier Than You Think
- From Policy To Practice: Embedding Export Compliance In Clinical Supply
- What CAPAs Don't Catch: 3 Hidden ATMP Cold Chain Vulnerabilities By Design
- AI And Digital Tools Advance Clinical Trial Supply Chains
- Solving Pharmacy And Clinical Supply Challenges In Decentralized Trials
- How The Strait Of Hormuz Crisis Is Stalling U.S. Medical Breakthroughs
- The Hidden Bottleneck: Clinical Supply Strategy In Study Start-Up
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Finding An RTSM Software To Keep Up With A Small Biotech
Stop letting rigid RTSM builds stall your oncology trials. Learn how agile configuration and right-sized documentation keep Phase I studies on track during frequent protocol amendments.
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7 Key Considerations For Designing The Optimal IRT/RTSM
Sponsors can create IRT/RTSM systems that are not only efficient and reliable but also adaptable to the evolving needs of clinical research by focusing on these seven key considerations.
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Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours
The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.
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Writing Effective Clinical Regulatory Documents For Therapy Trials
Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.
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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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When Protocol Amendments Meet RTSM: From Headache To High-Performance
Learn why an RTSM solution should be adaptive and flexible, and should help clinical trial teams uncover the best ways to handle protocol amendments.
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FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study
Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.
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3 Study Areas Where Your IRT Vendor Should Do More
Find out how advanced IRT systems now support diverse trial designs and how the expertise of RTSM vendors is crucial for tailoring solutions to trial needs and providing ongoing support.
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Breaking Down Early Small Molecule Development
Adopt an integrated development strategy to streamline the path from early development to the clinic, ensuring timely clinical supply while reducing delays, risk, and inefficiencies.
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Developing Injectable Drug Placebo Formulations For Clinical Trials
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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.