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TransCelerate's Clinical Quality Management System: From a Vision to a Conceptual Framework
Ann Meeker-O'Connell1, Leslie M Sam2, Nanci Bergamo3
11 BioResearch Quality and Compliance, Johnson & Johnson, 1 Johnson and Johnson Plaza, New Brunswick, NJ, USA.
Therapeutic Innovation & Regulatory Science
|September 19, 2018
Summary
TransCelerate BioPharma Inc developed a flexible clinical Quality Management System (QMS) framework to improve clinical trial management. This initiative aims to harmonize regulatory expectations and expedite patient access to new treatments.
Area of Science:
- Clinical research operations
- Regulatory science
- Quality management systems
Background:
- TransCelerate BioPharma Inc's Quality Management System (QMS) initiative identified the need for a flexible, proactive clinical QMS framework.
- Current clinical trial environments are complex, potentially delaying patient access to treatments.
Purpose of the Study:
- To chronicle the evolution of a proposed clinical QMS framework concept.
- To review global stakeholder feedback on the proposed framework.
- To describe efforts to harmonize regulatory expectations for clinical QMS.
Main Methods:
- Concept paper development and evolution.
- Global stakeholder feedback collection and review.
- Engagement with regulators for harmonization.
Main Results:
- Stakeholders recognized the framework's potential to inform harmonized International Council for Harmonisation (ICH) guidelines.
- Regulators' expectations for clinical QMS clarity is a key benefit.
- Ongoing development of tools and resources to support framework implementation.
Conclusions:
- A flexible, proactive clinical QMS framework can enhance clinical trial management.
- Harmonization of regulatory expectations through ICH guidelines is a significant outcome.
- Further development of supporting tools is underway to facilitate practical application.
Keywords:
QMSTransCelerateclinical developmentclinical qualityissue managementknowledge managementrisk managementMore Related Videos
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