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 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

  • Should Sponsors Provide Source Document Templates?

    Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats. 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