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

  • An Interview With Franco Negron

    Simtra’s capability to support high-volume injectables and lower-volume modalities provides balanced expertise across the sterile injectables landscape. read more

  • Leveraging AI and ML to Optimize Drug Discovery – a CRO Perspective

    CROs supporting early-stage drug discovery projects are establishing their own internal AI platforms to address their clients’ needs in an evolving field. 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