• 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
  • AI in Pharmacovigilance: Key Takeaways from Boehringer Ingelheim’s Recent Rollout

    In conversation with Pharmaceutical Outsourcing, Claudia Lehman, Head of Global Pharmacovigilance Operations at Boehringer Ingelheim and Lucinda Smith, ArisGlobal’s Chief Safety Product Officer, reflect on some of the lessons learned from Boehringer’s deployment of AI to date in targeted use cases, starting with adverse event case intake and processing. 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
  • Should Sponsors Provide Source Document Templates?

    Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats. read more