🎁 We have a present for you! December insights are here. This year brought collaboration, innovation, and new ideas to spark critical conversations. As we gear up for 2025, here are some resources to keep you inspired into the new year.
CluePoints
Software Development
Avenue Albert Einstein 2A, Louvain-La-Neuve 10,341 followers
AI-Powered Risk-Based Quality Management (RBQM) & Data Quality Oversight Solutions
About us
CluePoints is the premier provider of RBQM and data quality oversight software. We’re leveraging the potential of AI using advanced statistics and ML to determine the quality, accuracy, and integrity of clinical trial data both during and after the study. Aligned with guidance from the FDA, EMA, ICH, and MHRA, CluePoints supports central and on-site monitoring, medical review, and quality risk management to drive a holistic risk-based strategy. Coupled with thought leadership and consulting expertise to aid risk assessment and solution implementation, the result is positive clinical development outcomes, increased operational efficiency, lower costs, and reduced regulatory submission risk as part of the industry paradigm shift to RBQM. To learn more about CluePoints, visit CluePoints.com.
- Website
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https://cluepoints.com/
External link for CluePoints
- Industry
- Software Development
- Company size
- 201-500 employees
- Headquarters
- Avenue Albert Einstein 2A, Louvain-La-Neuve
- Type
- Privately Held
- Founded
- 2012
- Specialties
- Central Statistical Monitoring, Risk-Based Monitoring solutions, risk-based quality management, and ICH E6 (R2)
Locations
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Primary
New Tech Centre
Avenue Albert Einstein 2A, Louvain-La-Neuve 1348, BE
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1000 Continental Dr
Suite 240
King of Prussia, Pennsylvania 19406, US
Employees at CluePoints
Updates
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Reflecting on the 2nd Annual ACDM: Association for Clinical Data Management Symposium, where ACDM Board member and CluePoints' Richard Davies, shared insights on implementing Risk-Based Quality Management (RBQM). While the journey to adopt risk-based approaches in clinical data management can be challenging, it's crucial to engage and persuade stakeholders. #clinicalresearch #clinicaldatamanagement #clinicaltrials #RBQM #acdm
“The challenges of implementing RBQM are organisational…… there are a lot of hearts and minds to persuade that risk-based approaches are the right thing to do…… and that takes time” Looking back at the 2nd Annual ACDM: Association for Clinical Data Management Symposium on Risk Based Quality Management in October 2024, we’re reflecting on the discussion and knowledge sharing that took place. Richard Davies, ACDM Board member and Chair of the ACDM RBM Expert Group, provided insights from his own expertise as CluePoints Vice President, Solution Expert. ACDM Symposia are in-person two day events that take a deep-dive into specific areas of clinical data management. 2025 will see the 4th Annual ACDM Symposium on Artificial Intelligence in Clinical Trials, and the 3rd Annual RBQM Symposium. As well as the RBQM Symposia, the ACDM’s RBQM Expert Group meets s on a monthly basis to share thought leadership and experience in implementing RBQM and different approaches to monitoring and processing clinical data. Learn more about becoming an ACDM Member and Expert Groups (DMEGS) here: https://acdmglobal.org #clinicalresearch #clinicaldatamanagement #clinicaltrials #RBQM #acdm
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Standard medical coding relies on rules-based auto-coding with manual review by two coders. Traditional tools auto-code 70–80% of terms, leaving 20–30% for manual coding—time-consuming, error-prone work. To address this industry challenge, CluePoints launched Intelligent Medical Coding. 🙌 Keep reading our blog to learn how a major CRO cut coding time by 55%: https://hubs.ly/Q02--GnB0 #ClinicalTrials #ClinicalResearch #MedicalCoding
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Got some downtime this holiday season? Perfect for brushing up on your #RBQM knowledge! Catch up with our on-demand sessions to stay ahead in 2025. Access them here: https://hubs.ly/Q02--Lmf0
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CluePoints reposted this
FDA’s Office of Biostatistics has experience with a centralized statistical monitoring tool as part of an ongoing Cooperative Research and Development Agreement between CluePoints Inc., and FDA. Learn more in this audio podcast with Dr. Paul Schuette and Ms. Xiaofeng (Tina) Wang at 🎙️ https://lnkd.in/eURD4p2E or 📚 read the transcript at https://lnkd.in/eR5ZVGVD
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🚀 Exciting News! Dive into our latest article on the crucial role of central monitoring in early-phase and small enrollment trials. Key points: 🔍 SDM Tool: 78% adoption overall, with 73% in Phase 1, 79% in Phase 2, but lower in smaller trials—67% for 100 or fewer patients, 48% for 50 or fewer. 🌟 KRI Tool: 89% adoption, popular in all trial phases. 📈 QTL Tool: 32% overall, but higher in Phase 1, Phase 2, and small trials with 50 or fewer patients at 46%, 38%, and 38%. For up to 100 patients, it matches the overall rate. Check out the full article for more insights! https://hubs.ly/Q02_tZvV0 #ClinicalTrials
Central Monitoring Use in Early-Phase and Small Enrollment Trials
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What an incredible experience at SCDM India! 🌟 Richard Young had the honor of chairing the leadership panel discussion, "Clinical Data Management to Clinical Data Science: Unleashing the Power of Data Insights," featuring insights from leaders at Sanofi, ICON, AstraZeneca, Novo Nordisk, GSK, J&J, and Bioforum. Shay Deegan led a compelling panel discussion, "Empowering Clinical Data Management: Leveraging Language Models, AI, and Analytics for Enhanced Efficiency and Insights," joined by experts from Pfizer, ThoughtSphere, Accenture, and Hexaware Technologies. It was a fantastic opportunity to connect with industry leaders and explore the transformative potential of data science, AI, and analytics in clinical trials. Looking forward to continuing the conversation and driving innovation in clinical data management! 🚀 #SCDMIndia #ClinicalDataManagement #AI #ClinicalTrials
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The Site Profile & Oversight Tool (SPOT) offers cutting-edge adaptive site monitoring with a dynamic, data-driven approach to identify at-risk sites in real time, optimize resources, and streamline monitoring. Launched earlier this year, SPOT has already earned recognition from the clinical R&D community as a 2024 Citeline Awards finalist. 👏 Learn all about it: https://hubs.ly/Q02--GgT0 #ClinicalTrials #ClinicalResearch #DataOversight
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As the days get colder and the pace slows, it’s the perfect time to jumpstart 2025! ❄️ Our exclusive webinar, “Planning for 2025: Navigating the Future of RBQM,” was a huge success—and now it’s available on-demand. Cozy up, dive in, and gain insights to refine your risk-based strategies for the new year. Watch now: https://hubs.ly/Q02--_Vj0 #ClinicalResearch #RBQM #2025Outlook
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There’s a reason why “The Ultimate Guide to RBQM” is our most downloaded resource. 🤷♀️ Dive into proven best practices and a step-by-step implementation framework to roll out and adopt RBQM with confidence. Don’t miss out—download it now: https://hubs.ly/Q02--RtY0 #ClinicalTrials #ClinicalResearch #RBQM #DataOversight