Friday, May 16, 2014

How is Bristol-Myers Squibb moving to Quality by Design (QbD)

Bristol-Myers Squibb is piloting a new attempt at risk based monitoring. Applied Clinical Trials recently took an in-depth look at how they're implementing this new system.

They identified three key sectors: data operations, centralized monitoring and on-site monitors.  The data operations team in charge of data management.  From there, the centralized monitoring team is in charge of identifying unusual trends that they see appear in the data.  This team specialized skills in analytical, communications and critical thinking and are a great force when it comes to pushing forward with change in the process.  Finally, the on-site managers look into the unusual trends the data identifies.  

While efforts to implement QbD did provide a cost savings, BMS points out that it was not the main focus.  It also gave way to early error detection.

This September, the Partnerships in Clinical Trials Asia event will host a full morning of events focusing on Quality Control In Global Clinical Trials.  Sessions will look at quality driven drug development, data quality of clinical trials in China and how risk-based quality management can reduce costs of clinical trials in Asia.  For more information on these sessions, download the agenda.  If you'd like to join us in Shanghai this September 16-18, as a reader of this blog, when you register to join us and mention code XP1975BLOG, you'll save 15% off the standard rate!

What are of the key benefits of quality by design for clinical trials?






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