• 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
  • Patient-Centric Drug Delivery

    Across modalities and markets, patient-centric drug delivery is converging on three themes: self-administration at home, integration of drug delivery device platforms earlier in clinical trials, and alignment of formulations with device and human factors requirements. read more
  • The Tough Decisions

    While there are many drugs to make the end of life easier and less painful, the fundamental problem of deciding when to end life is a topic and a decision few want to address. read more
  • Representative Environmental Monitoring: Why Monitoring Activities Are Not Interchangeable Within a Contamination Control Strategy

    Environmental monitoring activities should not be assumed to be interchangeable because contamination control questions are not interchangeable. Different contamination control questions require different information. Environmental monitoring exists to generate that information. read more