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Quality Management System


Currently, industry guidance for quality in clinical development is fragmented across multiple documents from multiple sources.  The regulators require improved quality, the inspectors are expecting QMS to be operating effectively. While quality systems exist in other industries such as pharmaceutical manufacturing and aviation, there is no industry-wide conceptual framework for clinical Quality Management that aims to address quality and monitor and improve performance in complex clinical development-specific environments.

Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative has aimed to explore ways to improve quality across the industry.


The benefits of the Quality Management System Initiative include enhanced patient safety by improving quality, assuring data integrity, minimizing delays in clinical trials and bringing drugs to market more quickly.

Benefits for Sponsors:

  • Improved image and credibility of medical research through increased commitment to improve patient safety, data reliability, and data integrity
  • Greater ability to solve repetitive quality issues which individual companies have been unable to tackle on their own, through collaboration

Benefits for Sites:

  • Decreased burden on the sites by streamlining clinical trial processes and focusing on measuring “Issues That Matter”

Benefits for Patients:

  • Increased safety during clinical trials
  • Fewer study delays through reduced remediation associated with quality issues
  • Increased efficiency through reduction of remediation associated with addressing quality issues, ultimately getting drugs to market faster

Benefits for Regulatory Authorities:

  • Increased ability for industry to proactively adapt to Regulatory changes
  • Provides consistent quality framework for Regulatory Authorities to evaluate and measure “Issues That Matter”

Available Assets

In May 2016, the QMS Initiative developed a Clinical QMS Conceptual Framework Paper published in the DIA journal Therapeutic Innovation and Regulatory Sciences. The Conceptual Framework describes a proactive approach and flexible framework for holistically managing quality across the spectrum of clinical activities. The framework is intended to enable consistent delivery of reliable data that may be used by an organization, its partners, regulators, clinicians, sites and patients to make informed decisions.

Subsequent publications have included topic-specific manuscripts on Issue Management and Clinical Knowledge Management, as well as a tool for sponsors to Assess their Clinical QMS (ACQMS) according the elements laid out in the original paper, and other materials, all available for industry use.

For more information about the QMS Initiative, please click to Initiative Assets to learn more.




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