Latest Articles

  • From Lunar Orbit to First in Human: The High Stakes of Bold Science

    Much like the literal moonshots now back on the launch calendar, first in human studies are defined by the tension between danger and possibility. They are where bold ideas either earn the right to move forward or are stopped before they can do more harm than good. As an industry, our challenge is to keep reaching for those transformative rewards while taking the risks - scientific, financial, and human - every bit as seriously as a crew strapping in for a flight around the Moon. read more

  • 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