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FEATURED ARTICLES
Lessons In Pivoting From A Clinical Trial Launch In Uganda
Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
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What Is Computer Software Assurance, And What Are Its Benefits?
Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.
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The FDA Is Rudderless And Clinical Trials Are Left Adrift
Former commissioner Marty Makary, MD, left the FDA in May 2026. In his wake, he left an agency facing yet another wave of uncertainty. Denise N. Bronner attempts to navigate the latest change and offers advice for those seeking stability.
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Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community
CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.