Latest Articles

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

In conversation with Pharmaceutical Outsourcing, Claudia Lehman, Head of Global Pharmacovigilance Operations at Boehringer Ingelheim and Lucinda Smith, ArisGlobal’s Chief Safety Product Officer, reflect on some of the lessons learned from Boehringer’s deployment of AI to date in targeted use cases, starting with adverse event case intake and processing. read more