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Commentary|Podcasts|May 7, 2025

Unifying Industry to Better Understand GCP Guidance

In 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.

David Nickerson, head of clinical quality management at EMD Serono, executive sponsor of TransCelerate's ICH E6(R3) Initiative & PhRMA topic lead on the ICH E6(R3) Expert Working Group; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, and ACRO member participating in the ICH E6(R3) Initiative with TransCelerate, discuss:

  • The newest ICH E6(R3) GCP guidelines
  • Industry collaboration through TransCelerate and ACRO's partnership
  • Tools to help stakeholders better understand the latest GCP guidelines
  • Their own recommendations for best practices in risk management and data governance
  • and more!

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