The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products.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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Technology Solutions That Help Optimize Clinical Trial Distribution And Supply
Explore how interactive response technology (IRT) can solve some common challenges of manually managed clinical trials and how to find the best IRT solution that meets clinical trial requirements.
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Study, Not Software: Aligning RTSM To The Protocol
How can RTSM platforms improve your clinical trial and how do they integrate with your crucial trial systems?
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Sample Sizes For Performance Testing Of Combination Products, Packaging
When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
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Integrating Early-Phase Clinical Supply Manufacturing & Distribution
A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.
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Analytics–Powered Approach To Patient Recruitment Strategy
In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.
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RTSM: Randomization And Cohort Management, IP Inventory Management
Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
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GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm
Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.
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How Modern Software Architecture Is Revolutionizing IRT Solutions
Explore the ways technology suppliers across the clinical trial space have begun investing in IRTs built around a microservices model capable of improving data access and visibility.
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RTSM Manages Clinical IP Dispensation In Schizophrenia Study
Challenged by the dispensation of an investigational product (IP) across diverse patient subgroups, see what solution this pharma was able to utilize to ensure optimal distribution and minimize wastage.
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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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| Insights from Catalent's Clinical Supply Experts |
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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.