• 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
  • How Sports Stars and Drugs Keep Getting Reinvented

    Reinvention is everywhere. Products get updated, industries change course, and ideas we once treated as finished suddenly come back in a new form. Something that felt permanent five years ago can look completely different today, redesigned for a new audience or a new moment. read more
  • Rethinking the Architecture of Adverse Event Processing

    Deploying AI agents to handle data collection, coding, medical review, and quality-checking makes signal management autonomous at the processing stage. read more