• Engaging with Regulators for Single-Arm Oncology Research Trials

    When well-planned and well-executed, single-arm trials can accelerate access to life-saving therapies that might otherwise never reach desperate cancer patients. read more
  • Extreme Language Ultra-High Potency

    The newest generation of small-molecule therapies bring containment needs well beyond those of conventional HPAPIs. What does this mean for the pharma lexicon – and the pharma landscape? 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