• Flexibility as a Core IND Strategy

    With the increasing complexities of current IND programs, it is critical to work with regulatory agencies to seek input early in the process. read more
  • Why 2026 Is the Year Clinical Trials Stop Drowning in Data

    Rich data sits across systems; actionable insight does not. Making clinical decisions on the back of mountains of collected data, without the systems to connect it all together, is like trying to understand the mood of a restaurant by looking at each patron individually. read more
  • The Build-vs-Buy Decision About Connected Devices Just Got Easier

    Sponsors making decisions about device programs this year are setting more than just cost expectations for device procurement. They’re deciding whether devices will be a limiting factor on representative data or whether a partner who owns the full device strategy — not just the hardware — can enable broader, more diverse trials than would be possible by going directly to a manufacturer or managing it internally. 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