Looking to the Future with RBQM - DIA Global Forum
Looking to the future, RBQM can be applied across studies, programs, and organizations alongside machine learning and artificial intelligence to identify program, organization, or …
Implementation of Critical to Quality Factors (CtQ) in a Clinical Trial
Critical to Quality (CtQ) factors, cited and explained in ICH E8 (R1), are designed to confirm that a clinical study is designed to answer the research questions and to focus on monitoring …
Part 1: AI and Data Quality in a Decentralized World
RBQM applies this principle to the entirety of a clinical trial, allowing sponsors to manage data quality continuously. Advanced statistical methods have been highly effective at powering …
Selecting a Risk-Based Monitoring Vendor: Ensure Compliance
It also specifies that the monitoring plan should define the specific risks that the monitoring must address. Since all quality management processes are dynamic, the 2013 EMA Reflection …
September 2020 - globalforum.diaglobal.org
Elements of RBQM can be implemented individually and independently to great success, making clinical trials better, faster, and cheaper for sponsors and CROs – and safer for patients.
Navigating the Data-Driven Transformation of Clinical Development
A rising tide of clinical trial data is flooding the pharmaceutical industry, offering boundless potential to chart new development pathways.
Statistics Powering Risk-Based Quality Management
CluePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical trial data with digital or remote tools (eCOA, ePRO, etc.) …
Lower Costs, Shorter Timelines, and More Successful Study …
The clinical research industry is currently in a transition as it moves to adopt Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) as its primary quality management …