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ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?

The ICH E6(R3) draft guideline document, currently open to public consultation, places the industry firmly in the risk-based era, making it clear that the benefits of comprehensive operational oversight and targeted data management are in no way limited to the process of monitoring alone.

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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
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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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