Latest Articles

  • Status Of AI Regulation On Drug Development

    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

  • An Interview With Kim Boericke

    Veristat’s new CEO, Kim McLean Boericke, is one step closer to changing the tide in representing the small fraction of companies led by women and is now the only female with the highest job among the top-8 clinical research organizations (CROs). read more

  • From Service Provider to Strategic Partner

    As drug development grows more complex and timelines compress, sponsors require CDMO relationships built on integration, flexibility, and shared accountability read more

  • Safely Scaling Highly Potent API manufacturing

    Ever more drug developers are searching for CDMOs with contamination-limiting capabilities. But how can they know which have these high-potency credentials? read more