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How Roche Reduced Unnecessary Protocol Amendments to Impact Timeline and Cost

Roche developed the Protocol Amendment Decision Tool to help reduce unnecessary amendments and collect key data/insights on planned protocol amendments to inform continuous improvement strategies. 

October 21, 2025
How Roche Reduced Unnecessary Protocol Amendments to Impact Timeline and Cost
About this podcast: 

Liz Thompson, Global Development Leader, Senior Clinical Development Scientist at Roche, presented how the organization had delivered a single, cohesive protocol amendment categorization process to reduce the number of amendments and create a continuous improvement strategy, all to speed up timelines and reduce costs. This presentation comes from the September 2025 DPHARM: Disruptive Innovations to Modernize Clinical Research program. 

More specifically, Ms Thompson discusses how Roche is: 

  • Leveraging historical amendment data to enable study teams to understand why protocols are being amended
  • Utilizing a visual data science platform to generate insights from data to make better data-driven decisions
  • Applying retrospective learning into current protocols to curb the need for amendments
  • Building in business value 


For more information, go to DPHARMconference.com.


In this podcast

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