Is Agentic AI The ‘Next Leap Forward’ for Clinical Trial Data Management?
In clinical trials, every second counts, both for patient outcomes and sponsor ROI. As data volumes grow and oversight expectations tighten under frameworks like ICH E6(R3), teams are being asked to do more, faster and with greater precision. It is no surprise then that agentic AI, which promises to deliver efficiencies far beyond previous models, is the current hot topic […]
When Women Thrive, We all Rise
The theme for this year’s International Women’s Day (IWD) on 8th March was ‘Give to Gain’. The campaign aims to encourage a mindset of generosity and collaboration, emphasising the power of reciprocity, knowledge sharing, and support.
Quality Tolerance Limits: Why Breaches Happen Early and How to Act Fast
Quality tolerance limits (QTLs) are trial-level thresholds on critical-to-quality (CtQ) factors—key measures where sustained deviation could affect safety or primary conclusions. They should be a small set of guardrails that trigger timely investigation and documented decisions within risk-based quality management (RBQM).
Transitioning to risk-based clinical trial management under ICH E6(R3)
Risk-based quality management (RBQM) is becoming central to clinical trial oversight, with ICH E6(R3) emphasising proportional, patient-focused approaches. Sponsors and CROs are moving away from rigid monitoring plans toward strategies that embed quality throughout trial design and execution.
A Signal Isn’t Resolved Until It Stays Closed—RBQM Lessons
Analysis of more than 880 clinical trials shows that while statistical data monitoring and key risk indicator signals close on similar timelines, durability—not speed—is the defining differentiator in effective, risk-based quality management.
PharmaVoice’s Crystal Ball: What’s next for AI and drug R&D
As AI finds solid footing in pharma R&D, the technology is slated to yield significant rewards. Industry leaders expect that up to 30% of preclinical work could soon be accomplished using some form of AI, according to a recent survey, and ultimately predict a 16% reduction in drug development costs with the use of AI in […]
Trendspotting: Embracing AI, DEI Changes, Restrategizing Research Sites
To kick off 2026, we spoke with industry experts and leaders in the Clinical Research News community about what they expect and look forward to in the new year. More than ever before, artificial intelligence took center stage.
CluePoints: how proactive oversight and AI are reshaping clinical trial data management
Dan Beaudry, market owner for risk-based quality management (RBQM) at CluePoints, explains how regulatory shifts and AI-driven tools are transforming clinical trial data oversight. With ICH E6(R3) introducing risk-based approaches and the FDA signaling growing acceptance of algorithmic support, sponsors and CROs are operationalizing RBQM with adaptive site monitoring, automation, and predictive analytics. According to […]
Six geese a-laying: CluePoints’ AI predictions for 2026
Returning to the series is CluePoints, with Sophie Henderson, senior strategic consultant, sharing her hopes and expectations for how AI, analytics and risk-based approaches will continue to shape clinical development. From agentic AI to trust, transparency and smarter decision making, these predictions explore how the industry can turn technological potential into real-world impact in the […]
Predictions for the Future of Risk-Based Quality Management (RBQM)
Regulatory changes, including the launch of ICH E6(R3) and Good Clinical Practice (GCP) updates, have highlighted the value of, and need for, risk-based quality management (RBQM) approaches. With benefits including higher quality in clinical trial implementation and lower monitoring costs, the average proportion of clinical trial implementing RBQM is expected to increase to around 80% […]
