The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.
- A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development
- What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
- What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish
- New Group Wants 'Phase-Appropriate' Thinking To Retire
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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IRT? RTSM? What's The Difference?
What are the components of Randomization and Trial Supply Management (RTSM) and the critical role of RTSM and Interactive Response Technology (IRT) in clinical trials?
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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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3 IRT Tactics Being Used To Streamline Supply Logistics
Shipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.
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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.
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Enhancing Quality And Efficiency Through Digitized Clinical Secondary Packaging Processes
Explore how an innovative software platform can be used to create customized, user-friendly applications to digitize clinical secondary packaging processes.
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Cryobag Container Development For Cell & Gene Therapies
ISR Reports addresses the logistical challenges faced by developers of cell and gene therapies regarding cold chain and cryopreservation.
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Biosample Tracking: A Consenting Dilemma
Biosample collection is an inevitable part of most clinical trials. Learn how sponsors should be tracking every sample back to the source so as to not violate compliance issues.
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Bespoke RTSM Systems Empower Precision Medicine
Randomization & trial supply management (RTSM) are critical functions of clinical trial IRT systems, supporting patient randomization plus managing drug inventory, site resupply, and participant dispensation.
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Providing Drug Supply Support In Complex Environments Through IRT
Learn how applying predictive data analytics can enable the creation of an ideal supply strategy capable of reducing the need for extra shipments, manual oversight, and supply waste.
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How Pharmaceutical Manufacturers Can Take Control Of Their Supply Chain
In an increasingly competitive and regulated landscape, the right ERP system is no longer optional—it’s essential to reclaim control and drive growth in pharmaceutical manufacturing.
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.