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FEATURED ARTICLES
The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development
Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.
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Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.
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Why Africa Could Be The Next Frontier For Clinical Trials
Africa hosts only about 3% of global clinical trials despite representing roughly 20% of the world’s population. Tariro Makadzange, founder and CEO of the Africa Clinical Research Network (ACRN), explains how the organization aims to build a continent-wide clinical trial platform and increase that share to 15% over the next decade.
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Challenges That Derail Bladder Cancer Trials And How To Anticipate Them Earlier
From the rapid evolution of standard-of-care benchmarks to the logistical strain of procedure-heavy urology workflows, the path to a successful endpoint is filled with operational friction.