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Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters

Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and suggest ways of implementing quality tolerance limits (QTLs) alongside existing risk-based quality management methodologies.

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10 Steps for Practical RBQM Implementation for Your Business
  • Many clinical trial Sponsors and Contract Research Organizations (CROs) realize the great benefits of risk-based quality...
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The Bold Future of RBQM for CROs
  • In a world where complacency is the enemy of progress, Contract Research Organizations (CROs) stand at...
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Meet SPOT: Transforming Site Monitoring Practices with Adaptive Intelligence
  • Site monitoring is one of the most expensive components of clinical trials; on-site monitoring alone accounts...
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