Quality and Compliance Domain of the Citeline Maturity Model for Clinical Trial Disclosure
Article
薬事規制関連支援サービス
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
ライフサイエンス分野で20年以上の経験を持つ戦略リーダーであり、現在はCitelineの透明性業務責任者を務めています。業界をリードするTrialScopeの情報開示ソリューションの戦略を指揮し、透明性に関する深い知識と実績を持っています。
トーマスは、情報開示要件や透明性のトレンドについてのオピニオンリーダーとしても高く評価されており、これまでに60以上のカンファレンスで講演し、40以上の出版物を執筆しています。また、裁判の透明性を尊重するソリューションを加速させることを使命とし、チームに力を与えることに情熱を注いでいます。
