Drug development has dramatically changed over the past ten years. Specifically when it comes to GxP compliance and validation. Many biopharma companies struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. In this white paper, Egnyte will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
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.