When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.
- 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
- Inside Arbor Biotech's In Vivo Gene Therapy Approach
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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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?
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Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C
This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.
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Winning The Race To FPI With Early Randomization And Trial Supply Management
Learn why the ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences.
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Avoiding The Risk Of A Non-Transparent Clinical Supply Solution
With the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.
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Optimizing IRT For Clinical Supply Management
Experts speak on supply capabilities within interactive response technology (IRT) – how flexibility is important to functionality and who to involve and which questions to ask in optimizing IRT for clinical supply.
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Top Clinical Research Themes And Trends
We analyzed web traffic, content downloads, social media engagement, webinar attendance, and other metrics to determine the themes that caught your attention and aligned with broader industry trends.
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Managing Complex Global Drug Distribution And Expiry
A global top-ten pharma company sponsored a complex, 8-year Phase III trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced.
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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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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.
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.