Risk-Based Monitoring
11 videos · last 6 months shuffled daily, then older videos newest first
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19:20 From Data Collection to Experience Orchestration: Breaking Trial Silos
In a segment from Medidata's From Dreamers to Disruptors podcast shared by SCDM, panellists from CRO and site backgrounds describe how siloed data management, medical review and central monitoring create rework for sites.
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59:36 Optimizing Clinical Data Management From Data Capture to Analysis
Signant Health and ThoughtSphere present an integrated approach to clinical data management for emerging biotechs and smaller CROs, covering data capture, consent and randomisation, data aggregation, targeted risk-based monitoring and biometrics.
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1:04:39 Panel: The Evolution of QTLs in Light of ICH E6 (R3)
A CluePoints panel of industry leaders discusses the ICH E6(R3) shift from quality tolerance limits to acceptable ranges, the distinction between KRIs and QTLs, and how to define important deviations.
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9:33 Centralized Statistical Monitoring Explained: How Modern Clinical Trials Detect Risk Earlier
GCP-Mindset explains centralized statistical monitoring, the signals it can catch early, and how it supports risk-based monitoring and data quality across sites.
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34:30 Season 4, Episode 6: A People-Focused Approach to a Risk-Based Future in Clinical Trials
Veeva's Unblinded podcast talks to Noeleen Turner, head of clinical data management at UCB, and Anna Hayes of Veramed about risk-based data management, change management and endpoint-driven design.
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2:01 A Quick Look at Clinical Trial Monitoring
Catalyst Clinical looks at the elements of clinical trial monitoring in this short animated video.
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1:03:20 Has RBQM Met TransCelerate's Expectations?
A CluePoints panel with speakers from Pfizer, Alexion, Janssen, Astellas and Regeneron asks whether risk-based quality management has met TransCelerate's original expectations, covering adoption, change management and SDV versus SDR.
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45:06 ICH E6 (R3) & E8 (R1) Guidance Update
CluePoints and ZS Associates trace monitoring guidance from ICH E6(R2) through E8(R1) and E6(R3), addressing misconceptions about risk-based monitoring, SDV, centralized monitoring and QTLs.
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59:36 RBQM Best Practices Defined by Leading Industry Working Groups
A CluePoints webinar with WCG's Avoca Quality Consortium and ACRO on RBQM best practices: adoption trends, regulatory alignment, QTLs versus KRIs and centralized monitoring metrics.
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1:02:09 Ken Getz on the Global Adoption of RBQM
Ken Getz of Tufts CSDD presents a survey of 125 companies on how widely risk-based quality management has been adopted, where maturity is lowest and what holds sponsors and CROs back, in a CluePoints webinar.
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51:04 R&D Productivity in Biotech Clinical Trials
A Fortrea panel discusses R&D productivity in biotech trials, including complex protocols, AI, site visits, predictive resourcing, risk-based quality management and biotech-CRO partnerships.