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FEATURED ARTICLES
How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy
Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.
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Enhance Your Recruitment & Retention Strategy For Rare Kidney Disease Trials
Though the burdens of developing treatments for rare kidney diseases are high, data-driven recruitment strategies and experienced CRO teams will help ensure accessible trials with strong enrollment.
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Rebecca Jackson: EHR-To-EDC Needs A Reality Check
Rebecca Jackson offers a candid reality check on EHR-to-EDC integration, AI, and clinical trial technology, arguing that innovation must solve real operational problems — not create new ones.
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What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care
Yelena Bushman, MBA, VP of cell therapy and transplant at CareDx, discusses the operational challenges of validating biomarkers for post-transplant care.