RBQM Elements Have Seen Limited Adoption in Trials, New Global Survey Finds
Despite the push for greater use of risk-based quality management (RBQM) in clinical research, adoption of its most commonly used components by sponsors and CROs is limited and perceptions of their benefits are still varied, new findings show
Industry Trends: Cycle Time to Resolve Risk Signals
Central monitoring aims to detect emerging quality-related risks proactively during a clinical trial, resulting in study team intervention to address any confirmed issues and thereby drive optimal quality outcomes.
The Role of KRIs in Process-Driven RBQM Success
Using key risk indicators (KRIs) can improve clinical trial data quality in 80% of the sites on average.
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters
Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and suggest ways of implementing quality tolerance limits (QTLs) alongside existing risk-based quality management methodologies.
Quality Tolerance Limits: A Review of Industry Trends
An expectation for the use of quality tolerance limits (QTLs) was formally established in the International Conference for Harmonization (ICH) E6 (R2) GCP guideline published in 2016.
The Role of Transferable Skills and Data Science in the Move to Digitally-Enabled Clinical Research
Clinical research is evolving rapidly, with the digitalization of trials creating a new modus operandi and a tsunami of new opportunities for critical thinkers with an eye for data quality.
The Eradication of False Signals in Monitoring
Risk-based approaches to monitoring clinical trials were brought to the forefront with an FDA guidance published in 2013.
Identifying Important Risk Indicators in Clinical Development
Key risk indicators (KRIs) are metrics designed to identify risks of specific interest to study teams and considered an essential component of centralized monitoring.
RBQM: A Natural Evolution to Achieve Gold Standard Clinical Trial Management (Pages 38-39)
The success of clinical development programmes, drug approval and marketing depends ultimately on the readability and reviewer-friendliness of the documentation.
Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes
Central monitoring, which typically includes the use of key risk indicators (KRIs), aims at improving the quality of clinical research by pro-actively identifying and remediating emerging issues in the conduct of a clinical trial that may have an adverse impact on patient safety and/or the reliability of trial results.
