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.
Causing a Wave of New Career Opportunities
Clinical research is in the grips of a revolution that has caused a wave of new career opportunities.
Achieving Successful Decentralized Trials by Leveraging RBQM and Centralized Monitoring Oversight
Virtual or decentralized clinical trials present a far more patient-centric approach to conducting clinical research, building convenience and flexibility into the process, and allowing participants to engage in trials from the comfort of their day-to-day environment.
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring
A central statistical assessment of the quality of data collected in clinical trials can improve the quality and efficiency of sponsor oversight of clinical investigations.