Data and Knowledge Manager, CluePoints
A Review of Critical Issues Detected Via Central Statistical Monitoring
Analysis assesses the relative percentage of quality issues detected via SDM that clinical study teams considered critical.
Using Machine Learning and NLP to Improve Central Monitoring Documentation
Study teams often face challenges in maintaining detailed and accurate documentation of risk signals.
Ukraine War's Impact on Clinical Research: Evidence from Key Risk Indicators
Overall rate of significant KRI results for sites located in Ukraine has consistently risen since 2021.
Industry Trends: Cycle Time to Resolve Risk Signals
Metric derived from CluePoints central monitoring platform assesses average total cycle time from risk signal creation until closure.
The Role of KRIs in Process-Driven RBQM Success
As challenges like regulatory adherence, cost, and timelines become more complex, sponsors are seeking out new ways to incorporate risk-based approaches.
Quality Tolerance Limits: A Review of Industry Trends
Industry sees high increase in the use of QTLs.
Identifying Important Risk Indicators in Clinical Development
Study indentifies trends in most commonly used KRIs.