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.
Unlocking the Potential of Risk-Based Quality Monitoring
Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) are shifting the clinical research landscape, dramatically accelerating the drug development pathway, driving data quality, and ensuring early risk detection.
Why Risk-Based Quality Management Represents the Future of Clinical Research
By empowering researchers to detect data quality issues in real-time, Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) have proven their value during the race for a COVID-19 vaccine in which trials required the processing of huge volumes of data from dozens of global sites.
Managing Clinical Trials Amid the Coronavirus Pandemic
Amid the ongoing Coronavirus pandemic, clinical trial sites are increasingly inaccessible for patients and site staff, and as regulators halt inspections, the pharma and biopharma industry faces numerous challenges to ensure patient safety, compliance, and data quality and integrity.
Effective Risk Management When Using eCOA and ePRO
The use of direct source data capture in clinical research is on the rise, both during clinic visits and remotely by patients.