Detecting Fraud in Clinical Trials Using Statistical Data Monitoring
“Identifying … potential data manipulation and data integrity problems” are an International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R3) requirement and foundational for ensuring research integrity. In this article, we examine statistical tests for continuous variables that have identified deliberate data manipulation in clinical trials and evaluate their […]
The Future of AI in pharma: Beyond the buzz to real-world impact
Artificial Intelligence (AI) continues to gain momentum in the pharmaceutical sector, but can it truly deliver the full-spectrum intelligence needed to improve clinical research outcomes, speed up insights, enhance patient safety, and ensure regulatory compliance?
Around the Health Tech World: Dr Laura Trotta, CluePoints
Dr Laura Trotta gives us an insight into her role at CluePoints and shares some of the lessons she’s learned so far
AI, Data and Partnerships: The Building Blocks for More Sustainable Clinical Trials
Sas Maheswaran discusses how artificial intelligence, data and strategic partnerships can make clinical trials more sustainable – both financially and environmentally.
5 minutes with… Andrew Cooper, CEO, CluePoints
Andrew Cooper, CEO, CluePoints, explores how AI is transforming clinical trials, the power of a purpose-driven culture and what it takes to lead with innovation and teamwork
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 […]
