Latest Articles

  • 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

  • Rethinking the Architecture of Adverse Event Processing

    Deploying AI agents to handle data collection, coding, medical review, and quality-checking makes signal management autonomous at the processing stage. 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

  • The Next Test for AI in Pharmacovigilance Is Trust, Not Accuracy

    An AI model can be right and still not be trusted. That’s what Bristol Myers Squibb (BMS) found six months into rolling out AI-powered adverse event processing: while F1 performance scores were tracking upward, the audit trail found reviewers still reopening cases the system had already cleared. read more