Risk Planning: A Review of Industry Trends
An essential component of risk-based quality management (RBQM), as detailed in both the ICH E8 (R1) and ICH E6 (R2) GCP guidelines, is to perform proactive assessments of risk starting with the initial design of a study, again during study planning, and as needed throughout study execution. Important risks identified at each stage should result […]
Achieving Optimal Adoption of Risk-Based Quality Management
The need to boost education, shift culture, and embrace new technologies.
The Negative Impact of Failing to Implement Risk-Based Quality Management
As an industry, we regularly discuss the benefits of adopting risk-based quality management (RBQM). The good news is that adoption is on the increase with companies implementing RBQM in 57% of clinical trials. However, there is still a way to go before RBQM becomes business as usual, and adoption rates are lower among smaller companies. […]
There’s No Such Thing as Too Much Data
François Torche dispels the myth that, at least in RBQM, there is such a thing as too much data, and discusses how advanced data analytics platforms are the key to ensuring every data point has a chance to share its story.
Using RBQM and New Technologies to Enhance Data Analysis and Enable Faster Review and Decision Making
An increase in clinical trial data is driving demand for enhanced clinical trial processes. Sponsors want to be able to review data which has been analyzed quickly and efficiently so they can make informed decisions faster.
Advancing Technology in Clinical Trials
With increasing pressure to overcome drug development challenges and advance drugs to market faster and with greater efficiency, sponsor expectations of CROs and their services are running high.
CRO Industry Report
Today’s drug development landscape demands contract research organizations (CROs) provide flexible models that leverage the latest technologies to support sponsor needs.
DIA 2024: Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM
In an interview with ACT editor Andy Studna at DIA 2024, Hughes, co-founder and chief commercial officer of CluePoints touches on collaboration with FDA and using artificial intelligence in clinical research.
Does Risk-Based Quality Management (RBQM) Actually Improve Quality?
Over the past 10 years we have seen a lot of progress in risk-based quality management (RBQM) adoption across the industry. This has rightly led to questions about its impact.
Quality Tolerance Limits: An Updated View of Industry Trends
We presented an initial review of quality tolerance limit (QTL) adoption trends in the March 2023 issue of Applied Clinical Trials, based on information compiled from the CluePoints RBQM platform through the end of 2022.
