Latest Articles

  • An interview with Franco Negron

    In this interview, we spoke with Franco Negron, CEO of Simtra, about how the company is advancing its position as a premier CDMO for sterile injectables while preparing for the next wave of complex biologics. read more

  • How Real-Time Data Analytics Can Address Common Pain Points in Clinical Trials

    Major issues in clinical oversight are latency and heterogeneity across systems including formats, identifiers, coding conventions, and timing of updates. 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

  • AI Technologies in Pharmacovigilance

    Leading pharmaceutical companies are predominantly applying AI to case intake and early case processing in PV, where rising Individual Case Safety Reports (ICSRs) volumes and diverse report formats have made manual handling increasingly unsustainable. AI is used to support data intake, extraction, and transformation up to the point where information can be integrated into the safety database, while downstream steps like case assessment and medical review largely remain human-led. read more