Making the Financial Case for Risk-Based Quality Management in Clinical Research- Q&A
New peer-reviewed research puts hard numbers to the financial value of RBQM, showing ROI multiples up to 23x and up to 19% shorter clinical phase durations, with time savings as the biggest driver.
The CRA of the Future
Clinical research associates are evolving from compliance-focused manual monitors to data-enabled strategic site partners, but organizations need analytics training, clear operating models, and active change management to make the shift stick.
Applying Risk-Based Oversight to Ensure Real-World Data Integrity
Clinical trials have undergone a period of immense change. Use of real-world data (RWD) is increasing. Regulators are backing both risk-based approaches and the use of real-world evidence (RWE). Artificial intelligence (AI) allows us to unlock better insights than ever before.
How RBQM Fits Into An AI World
How risk-based quality management (RBQM) can harness the power of AI and advanced analytics to transform clinical trial execution and oversight.
How agentic AI is shifting data management from time-consuming investigation to confident confirmation
AI is reshaping clinical data management (DM), moving the industry away from time-consuming, inefficient processes and towards continuous, intelligent oversight.
How AI and Advanced Statistics Are Helping Research Rise
Clinical trials are undergoing a period of change. Innovative uses of artificial intelligence (AI) are unlocking better insights. Regulators are backing risk-based approaches and a focus on the issues that matter. In this period of evolution, sponsors and CROs need to choose the right solutions—and the right partners—to help keep research rising.
Safety Reporting in RBQM: Bridging Risk Assessment, Monitoring, and Action
Safety reporting is a critical aspect of clinical trial quality, directly impacting patient safety and regulatory compliance. While risk-based quality management (RBQM) provides multiple tools to manage this risk, ensuring these tools operate in a coordinated and effective manner remains challenging. In line with International Council for Harmonisation (ICH) guideline E6(R3), which emphasizes proportionate and […]
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).