Key Risk Indicators
Key Risk Indicators are a set of metrics, pre-defined by the Sponsor or CRO, used to illuminate risks during the conduct of clinical trials. Key Risk Indicators may be qualitative or quantitative, and in most cases are determined by comparing data across protocols, countries or sites. KRIs are an essential component for achieving a Risk-Based Approach to Study Execution (RBx).
Quality Tolerance Limits
Guidance from both the ICH and FDA suggests that Sponsors should decide which risks to reduce and/or which risks to accept, using risk reduction approaches proportionate to the significance of the risks. This can be achieved by adopting Quality Tolerance Limits (QTLs), a set of trial-level parameters, defined and documented at the planning stage of trials.
Central Statistical Monitoring
Central Statistical Monitoring utilizes the CluePoints patented SMART engine to analyze all Clinical and Operational data within the trial and detect atypical data patterns. The results of Central Statistical Monitoring will show which Patients, Sites or Countries/Regions have atypical data patterns that could indicate sloppiness, tampering, systemic errors or fraud in the underlying data.
The practice of the ‘professional patient’, a subject that simultaneously enrolls in multiple trials, or across multiple sites for a single trial, is a growing threat to the safety of patients clinical research. Subjects may take multiple doses of the IP, or couple the IP dose with IP’s from other trials, thus creating data integrity issues that could impact the trial outcome.
Patient Profiles provide easy insight into patient journeys through your trial. Perfect for medical review, the rich, graphical nature of Patient Profiles enables a consolidated view of data from multiple sources, combining into a single visual timeline for each patient. Patient Profiles also overlay statistical analysis results to guide the reviewer to specific areas of interest in a patient record.
As Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM) have become more widely adopted, more experienced users need to extend the way they drill-down into risks and what matters most within their studies. The comprehensive nature of the analytics offered within the BEYOND module gives all users the data exploration tools and elegant visualizations they need to test their hypotheses and drive their critical thinking.
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ICH E6 (R2)
Created in conjunction with our peers at TUFTS Center for the Study of Drug Development, this paper provides insights on how companies are responding to ICH E6 (R2) and information on the key themes on adoption.
ICH E6 (R2)
This recorded webinar covers all of the frequently asked Questions about ICH E6 (R2), Risk-Based Study Execution (RBx) and what’s required from a people, process & technology standpoint.