Benchmarking Risks Across Therapeutic Areas
The monitoring of key risk indicators (KRIs) is an established form of risk control in the conduct of clinical trials. It is widely acknowledged that acceptable thresholds for KRIs vary by therapeutic area. However, the unavailability of benchmark data can limit the robustness of mitigations built into protocol and monitoring plans, in accordance with ICH […]
Where is RBQM Heading in The Future With AI?
Richard Young, Chief Strategy Officer at CluePoints, shares insights on AI and risk-based quality management (RBQM) in clinical trials. With experience at both CluePoints and Veeva, Young discusses AI’s role, transparency, and the future of risk management in clinical trials.
Think Tank 2025 Pharma Forecast: What Lies Ahead for the Industry in 2025?
The pharmaceutical industry is poised for a transformative evolution by 2025, driven by the possibilities of emerging technologies, regulatory shifts, personalized medicine, and lessons from recent global crises. Together, these trends will redefine the pharmaceutical landscape, setting a new standard for innovation, collaboration, and patient-centered care. PM360 asked specialists about what they believe the New […]
Central Monitoring Use in Early-Phase and Small Enrollment Trials
Central monitoring is highly effective in detecting emerging quality issues in clinical trials, but debate continues over its use in early-phase and small enrollment studies due to typically lower data volumes and shorter study timelines. In this analysis, we summarized industry trends in early-phase and small trials using data from the CluePoints central monitoring platform. […]
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.
