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

  • 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

  • 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

  • Beyond Case Management

    In large pharma, a staggering 40 to 50 percent of expert pharmacovigilance time is still consumed by tasks far removed from active, scientific PV - such as the mechanics of scheduling reports, tracking down contributors, and managing documents. read more