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.
Better Qualification Strategies, Better Patient Recruitment Outcomes
October 14th 2024As the clinical trial recruitment landscape continues to evolve, patient recruitment remains a critical challenge. More innovative screening strategies can improve recruitment and enhance the quality of clinical research.
Transforming Research: The Intersection of Ethics, Biosafety, and Innovation
October 14th 2024Increased interest in cell and gene therapies has led to a greater demand for expertise to help sponsors, CROs, and sites coordinate human gene transfer (HGT) research. Compared to clinical trials with older, more traditional classes of drug products, there are important similarities and differences in requirements for safe and ethical conduct of clinical trials of gene therapy and related modalities.
Empower Sponsor Success with Insights from Sites
October 3rd 2024Are you tired of clinical trial technology that slows down processes? Are your sites looking for more intuitive solutions? At YPrime, we’ve taken a deep dive into site experiences and perspectives, sharing ways to bridge the gap between sponsors, sites, and patients, to foster a more efficient clinical trial process.