Latest Articles

  • Under the Spotlight: Agentic AI

    In an interview with Pharmaceutical Outsourcing, ArisGlobal’s Jason Bryant discusses the premise of AI’s next high-profile incarnation, the technology’s potential in late-stage pharma R&D operations, emerging early use cases, and some of the guardrails that need to be in place to ensure trusted, impactful use. 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

  • Horizon Lines: A Quarterly Review of NDAs – October- December 2025

    This quarterly review of New Drug Applications contains data for applications approved for the first time during the last quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 40 applications were approved by the FDA during these three months. read more

  • Why DSCSA Compliance in 2026 Hinges on Execution, Not Implementation

    After a decade of ramp-up, the era of DSCSA enforcement is no longer theoretical — it’s here. But as we move deeper into this phase of full compliance, the real story unfolds not just in establishing data feeds, but in the operational cracks that persist behind the scenes. read more