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The Society of Clinical Research Associates (SOCRA) lists four common myths about quality in clinical trials:

  • Only auditors can implement quality systems and processes
  • Due to the many variables in clinical research, maintaining a quality system is not possible
  • Establishing, maintaining, and re-evaluating quality is expensive
  • Quality is a separate function and someone else’s responsibility

Both the ICH clinical practice and the GCP guideline recommend that we use systems and procedures that assure quality in every phase of a clinical trial.

The sponsor is responsible for implementing and maintaining quality assurance, ideally by implementing a next-generation EQMS that enables data-driven quality management.

Afterall, findings from an inspection can only improve quality processes in the future, but it cannot fix quality issues in the current batch of products. This applies to clinical research as well.

Discover the importance of integrating Quality into the Clinical Workflow in this whitepaper.

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