Quality and Compliance Domain of the Clinical Trial Disclosure Maturity Model
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Article 4 in our Maturity Model series
Executive Summary
The quality and compliance domain encompasses the systems, processes, and practices that ensure the accuracy, consistency, and regulatory adherence of clinical trial disclosure. This is fundamental to maintaining the integrity of disclosed information and building trust with regulators, healthcare professionals, and the public. Effective quality and compliance management in clinical trial disclosure goes beyond mere regulatory adherence. It involves creating a quality culture, implementing robust systems, and continuously improving processes to ensure that disclosed information is accurate, timely, and meets all applicable standards and regulations.
Why this domain matters
Quality and compliance are essential for trustworthy clinical trial disclosure. This domain focuses on the systems and practices that ensure the accuracy, completeness, and timeliness of the disclosed information. By prioritizing quality and compliance, organizations meet regulatory requirements and build credibility with stakeholders, from regulators and healthcare professionals to patients and the public. Strong performance in the quality and compliance domain supports:
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About the author
Thomas Wicks
Head of Transparency Operations, Citeline
Thomas Wicks is an experienced strategic leader with over 20 years in life sciences. As Head of Transparency Operations at Citeline, he spearheads strategy for TrialScope's industry-leading disclosure solutions. Thomas is an established thought leader, having spoken at over 60 conferences and authored over 40 publications on disclosure requirements and transparency trends. Thomas is motivated by empowering teams to accelerate solutions that honor trial transparency.
