Ensuring ongoing inspection-readiness of a Trial Master File can present challenges to even the most well-prepared organization - with unforeseen quality or completeness issues cropping up when least expected. To help identify and avoid the most common errors, Phlexglobal’s TMF experts have compiled a handy guide, “5 Reasons Your TMF Isn’t Inspection-Ready (and what you can do to fix it).” You’ll discover the top causes of inspection findings, as well as pragmatic steps to improve inspection-readiness. Want to reduce the uncertainty and risk of an inspection, and be better prepared to pass this critical test when it happens? Download the helpful guide today.
Mobile Visits in Decentralized Clinical Trials: The Past, Present and Future
May 7th 2024In March 2024, the US FDA issued its guidance, “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” outlining the agency’s objectives for protecting public health as artificial intelligence (AI) and other technologies become more prevalent in healthcare.
Digital Biomarkers Solution shows pathway to reduced clinical trial sample sizes, shorter durations
April 5th 2024Digital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.