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

  • HPLC-Based Strategies for Impurity Profiling and Validation in Standard Drug Analysis

    The control of pharmaceutical impurities is a fundamental objective in the development of drugs, focusing on the comprehension of the chemical structures of unidentified impurities. This understanding is essential for evaluating toxicological consequences and grasping the mechanisms of formation. API-related impurities, such as degradation and interaction, can affect drug product quality, safety, and efficacy. Classifying sources of impurities is essential for analytical method development and acceptance criteria. 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