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

  • The Operational Foundations That Characterize Regulatory Leaders

    Holding individuals and teams explicitly accountable for data accuracy and quality might seem straightforward, but it is difficult to sustain in practice. read more

  • We Have More Data Than We Know What to Do With

    Every year brings another round of headlines about pharma “drowning in data.” At this point, that’s less a warning than a permanent weather condition. read more

  • From Data to Tissue

    The national-security regulatory landscape now layers a geopolitical framework onto the data flows, sample logistics, and vendor relationships that make modern clinical research possible. This architecture will not simplify. The DSP’s country-of-concern list may expand, the BIOSECURE Act’s designated-entities list will likely grow, and state legislatures continue adding requirements. read more