Latest Articles

  • Status Of AI Regulation On Drug Development

    As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. read more

  • How AI is Transforming Clinical Trials

    AI is already reshaping the clinical trials industry and that transformation looks set to continue over the next five years. New technologies will enable the development of more personalized medicines, empower more responsive trial designs and improve informed decision making by unlocking new data insights. 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

  • Rethinking the Architecture of Adverse Event Processing

    Deploying AI agents to handle data collection, coding, medical review, and quality-checking makes signal management autonomous at the processing stage. read more