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

Rich data sits across systems; actionable insight does not. Making clinical decisions on the back of mountains of collected data, without the systems to connect it all together, is like trying to understand the mood of a restaurant by looking at each patron individually. read more