Latest Articles

  • Post-Approval Change Management

    Achieving global approval for a single change may take three to five years, but inefficient lifecycle change management rarely registers as a crisis. read more

  • Five Steps to Smooth Agentic AI Adoption

    In agentic AI-enabled labs, AI goes from individual, one-off applications to comprehensive workflow orchestration. read more

  • From Data to Tissue

    The national-security regulatory landscape now layers a geopolitical framework onto the data flows, sample logistics, and vendor relationships that make modern clinical research possible. This architecture will not simplify. The DSP’s country-of-concern list may expand, the BIOSECURE Act’s designated-entities list will likely grow, and state legislatures continue adding requirements. read more

  • The Next Test for AI in Pharmacovigilance Is Trust, Not Accuracy

    An AI model can be right and still not be trusted. That’s what Bristol Myers Squibb (BMS) found six months into rolling out AI-powered adverse event processing: while F1 performance scores were tracking upward, the audit trail found reviewers still reopening cases the system had already cleared. read more