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As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. read more

Clinical research organizations (CROs) are entering an era in which pharmacovigilance systems are doing more than just tracking copious amounts of data. They must also keep pace with evolving regulations, manage the growing volume of adverse event reports, and respond to heightened scrutiny from both regulators and the public. read more