Webinar
Implementing risk-based quality review for an inspection-ready TMF
Summer Shorts Webinar Series
Guidelines from the International Council for Harmonisation (ICH) and guidance from regulatory authorities have long endorsed a risk-based approach to clinical trials, including the Trial Master File. Many companies, however, struggle to develop and implement an effective risk-based approach to the TMF.
Guidelines from the International Council for Harmonisation (ICH) and guidance from regulatory authorities have long endorsed a risk-based approach to clinical trials, including the Trial Master File. Many companies, however, struggle to develop and implement an effective risk-based approach to the TMF.
Key insights
Discover how risk-based TMF quality checks (QC) and quality reviews (QR) can enhance TMF quality while saving time and resources. Learn the key differences between QC and QR, the various types of quality reviews, and how to apply them effectively. Additionally, identify common risks found in clinical documentation processes, even among experienced TMF teams, and present proven tools and methodologies that provide actionable insights into the risk profile of your Trial Master File. Chris Englerth, our Director of Global Consulting Services, moderated this session alongside Jake McDonald, our TMF Solution Consultant.
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