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RESEARCH & THOUGHTS

Perspectives Shaping Clinical Development

Discover engaging resources driving the conversation forward and on-demand demo videos showcasing the very solutions forming the future of our field.

Duplicate Patients
Specify configurable variables likely to indicate duplicates and review based on similarity scores and...
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Key Risk Indicators (KRIs)
Rank sites based on performance and tolerance metrics, uncovering ‘at-risk’ locations in need of corrective...
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Patient Profiles
Flag atypical patient patterns, prioritize investigations into anomalies within data sets, and determine...
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Quality Tolerance Limits (QTLs)
Identify systematic issues, monitor key metrics, and document deviations from pre-defined QTLs to ensure...
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Risk Assessment & Mitigation
Determine vulnerable trial areas, define risk controls, and monitor capabilities to detect evolving threat...
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Signals & Actions Tracker
Assess identified issues, annotate commentary, deploy automatic auditing, and leverage extensive exporting...
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Linear Mixed-Effects Models for Central Statistical Monitoring of Multicenter Clinical Trials
Linear Mixed-Effects Models for Central Statistical Monitoring of Multicenter Clinical Trials
Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials
Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods
Impact of On-Site Initiation Visits on Patient Recruitment and Data Quality in a Randomized Trial of Adjuvant Chemotherapy for Breast Cancer
Data Fraud in Clinical Trials
Examining the Current State of ICH E6 (R2) Adoption
From RBM to RBQM: The Future of Risk-Based Trial Management
Harnessing CSM to Drive Risk-Based Quality Management (RBQM)
Conclusions from Executive Roundtable on Response to ICH E6 (R2)
Implementing a Scalable Risk-Based Monitoring Strategy
Sponsor Responses to the ICH E6 Revisions
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Applying Risk-Based Quality Management To Investigator-Led Trials
From Risk-Based Monitoring To Risk-Based Quality Management
Webinar: The Future Of Clinical Trial Monitoring
New Paper: From RBM To RBQM – The Future Of Risk-Based Trial Management
RBQM Doesn’t Have To Be Complicated, Risky Or Expensive: Q&A
Beyond COVID-19: The New Normal In Risk-Based Monitoring (RBM) And Quality Management (RBQM)
Early Risk Detection During The COVID-19 Crisis – Your Questions Answered
Complimentary COVID-19 Risk Assessment Package Available To All At No Cost
Risk-Based Quality Management – It’s Now A Question Of “How” Rather Than “If”
Implementing A Risk-Based Quality Management Strategy – The Ultimate Guide
Transitioning From A Risk-Based Monitoring Approach To Risk-Based Quality Management
Risk-Based Study Execution (RBx) – It’s Time To Close The Loop!
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