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FEATURED ARTICLES
How The Quiet Data Standards Revolution Is Impacting Drug Approval
Principal Statistical Programmer Varun Debbeti details the role data standards play in approval timelines, detailing shortfalls of current the model and CORE, Dataset-JSON, and SDTM v3.0 stand to make an impact.
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Why Early Clinical Development Is Shifting Toward Decision-Enabling Study Designs
Early clinical research is shifting to decision-focused designs, using biomarkers, functional endpoints, and targeted populations to reduce uncertainty and enable clearer progression.
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What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And Use
Benchmarking is widely used and highly valued, yet trust in it is limited. The League Benchmarking Working Group has set out to standardize how site metrics are defined, contextualized, and applied.
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New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA
NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.