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

  • Rethinking Early-Phase Outsourcing

    The CDMOs that bridge the fulfilment gap and truly become partners are likely the best choice for biotechs and pharma looking to develop their early-stage asset. While most CDMOs are well-versed in providing services with regular communication, sharing strategic objectives with clients, and ultimately providing the final material, it’s the “above and beyond” CDMOs that provide the real added value. read more