Latest Articles

  • Hasty Decisions, Runaway Projects

    Despite the best intentions of ISO and EMA, the pharma industry is still largely failing to exploit its data in a strategic, joined-up way - and this could now restrict companies’ ability to capitalize on AI. read more

  • 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

  • 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

  • Flexibility as a Core IND Strategy

    With the increasing complexities of current IND programs, it is critical to work with regulatory agencies to seek input early in the process. read more