Latest Articles

  • 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

  • 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

  • An Interview with Rod Ketner, PhD

    Sponsors sometimes optimize too narrowly for the next milestone instead of the full development path. A formulation may be sufficient for an early study but still be poorly positioned for robust scale-up, transfer, or validation. That’s where delays and added costs show up. read more