Latest Articles

  • From Lunar Orbit to First in Human: The High Stakes of Bold Science

    Much like the literal moonshots now back on the launch calendar, first in human studies are defined by the tension between danger and possibility. They are where bold ideas either earn the right to move forward or are stopped before they can do more harm than good. As an industry, our challenge is to keep reaching for those transformative rewards while taking the risks - scientific, financial, and human - every bit as seriously as a crew strapping in for a flight around the Moon. read more

  • Engaging with Regulators for Single-Arm Oncology Research Trials

    When well-planned and well-executed, single-arm trials can accelerate access to life-saving therapies that might otherwise never reach desperate cancer patients. read more

  • An Interview With Franco Negron

    Simtra’s capability to support high-volume injectables and lower-volume modalities provides balanced expertise across the sterile injectables landscape. 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