Translational medicine; bench-to-bedside; agile development. All these terms use updated processes, new technologies and data to inform decisions earlier in clinical development. Supported by expedited regulatory pathways, which require extensive safety monitoring to accompany these earlier approvals, has made the gaps between preclinical and clinical a looming reality.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.