Operating Model and Governance Domain of the Citeline Maturity Model for Clinical Trial Disclosure
Article
薬事規制関連支援サービス
Article 6 in our Maturity Model series
Executive Summary
Disclosure process management is the systematic way of organizing and carrying out activities related to clinical trial disclosure. This includes creating, implementing, and overseeing clear and consistent processes for the accurate and timely disclosure of clinical trial information. Disclosure process management is not merely an administrative task but the foundation of effective clinical trial transparency. Strong performance in this domain is a prerequisite for consistent, efficient, and compliant disclosure practices. By implementing standardized processes, organizations can minimize errors, improve efficiency, and consistently meet regulatory requirements.
Why this domain matters
The disclosure process management domain is the operational core of clinical trial transparency efforts. It shapes how organizations execute their disclosure activities, from initial planning to final publication. Effective process management ensures disclosure tasks are performed consistently, efficiently, and in compliance with regulatory requirements, regardless of the complexity of the trial or the variety of disclosure obligations. Well-defined disclosure processes are essential for several reasons:
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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。
