2024 was remarkable for CluePoints’ Central Monitoring Platform. ✅750 studies analyzed—35% growth vs. 2023 ✅351 first-time study analyses—47% growth vs. 2023 This momentum spans Risk Assessment, Data Quality Assessment, Key Risk Indicators, and Duplicate Patients. And we’re just getting started—stay tuned for updated FDA & EMA approval numbers. Better data means faster approvals. Be part of the next breakthrough: https://hubs.ly/Q03bPj8L0 #ClinicalTrials #ClinicalResearch #RBQM
CluePoints
Software Development
Avenue Albert Einstein 2A, Louvain-La-Neuve 11,361 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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Set to impress. From real-world applications to best practices, our experts are bringing their insights to the stage: 🔹 Jamie O'Neill will dive into eCOA compliance and audit trail review using advanced statistical methodology, shedding light on how data-driven insights can enhance compliance and efficiency. 🔹 Rachael Geedey will discuss moving beyond checkboxes to a quality-driven approach to clinical trial risk assessments. Not here? Reach out, and we’ll catch you up: https://hubs.ly/Q03b4kkX0 #PHUSEConnect #ClinicalDataScience #RBQM #AIinClinicalTrials #DataOversight
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🎉 What a Deliciously Fun Pi(e) Day! 🎉 We had a blast celebrating and indulging in all the Pi Day creations! A massive thank you to everyone who joined in—you baked, we tasted, and now the results are in! Here are the champions of the 2025 CluePoints Pi Day Competition Best Looking Pies: 🥇Sophie Henderson – Cherry Pie 🥈Kelleigh Parker – Chocolate Peanut Butter Pie 🥉Brittany Bregman – Peanut Butter Cup Pie Best Tasting Pies: 🇧🇪 Benjamin Faguer- Chocolate Genoise Pie 🇺🇸Nicole Basta – Strawberry Swirl Cheesecake Pie A huge round of applause to our winners and a heartfelt THANK YOU to everyone who made this Pi Day unforgettable! Dive into these stunning creations and let's keep this delicious tradition alive! 🥧
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Let’s break it down. In 2024, CluePoints supported at least 32 FDA and EMA approvals, including 18 new drug approvals—4 supported across multiple phases—all based on studies utilizing Data Quality Assessment (DQA) or Key Risk Indicators (KRI). These successes span 13 Sponsors and 44 different studies, reinforcing the impact of our RBQM solutions. We’re proud to drive regulatory success with smarter data, deeper insights, and stronger approvals. Will your trials be part of the 2025 success story? Let’s talk: https://hubs.ly/Q03bNLGb0 #ClinicalTrials #ClinicalResearch #RBQM
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We are thrilled to announce the success of our collaborative event in Boston with Coronado Research, focusing on Exploring Innovations in Data Science and RBQM: Insights for the Future. This gathering united industry leaders, innovators, and experts to delve into advanced methodologies, AI-driven trial design, and proactive risk management strategies. We extend our gratitude to everyone who contributed to the event's success and look forward to future collaborations!
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The numbers don’t lie. At this rate, gender parity is over a century away. In STEM alone, equal representation isn’t expected until 2070. In our latest blog, women at CluePoints share personal insights on tackling bias, championing mentorship, and driving systemic change. Let’s challenge stereotypes, elevate voices, and make ambition the norm. Because gender equality isn’t just an annual conversation—it’s an everyday commitment. Read more and join the movement: https://lnkd.in/dFAZJsBw #InternationalWomensDay #WomenInSTEM
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Data tells a story. Our job is to help you read between the lines. From clinical data science to statistical programming and regulatory reporting, CluePoints’ AI-powered solutions transform how teams detect risks, streamline workflows, and make smarter decisions. Join us in Orlando to explore the power of integrated data review and experience the technology driving it forward. Let’s turn data into positive outcomes—together. Schedule a 1:1 meeting here: https://hubs.ly/Q03b4qt70 #PHUSEConnect #ClinicalDataScience #RBQM #AIinClinicalTrials #DataOversight
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We solve puzzles for a living—clinical trial data puzzles, that is. But the most important pieces? The people who bring it all together. 🧩 From AI innovators to data experts, problem-solvers to change-makers, every CluePoints teammate across the globe is essential to our success. To our team: You’re the heartbeat of our every breakthrough. Thank you for making CluePoints not just a workplace but a powerhouse of possibility.🚀
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CluePoints reposted this
Machine Learning, Computerised GCP Systems and Large Language Models and Regulations……ACDM25 Regulatory Breakout Stream…… > “How Machine Learning Can Automate Data Anomaly Detection, Streamlining Query Management to Accelerate Database Lock and Regulatory Submission” presented by John Hall (CluePoints) > “Introduction to the ISPE Good Practice Guide Validation and Compliance of Computerized GCP Systems and Data” presented by Frank Henrichmann (QFINITY Quality Management) > “Leveraging Large Language Models (LLMs) to Streamline Regulatory Submissions and Accelerate Clinical Trial Approvals” presented by Adriaan Kruger (nuvoteQ.io) #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #ACDM #ACDM25
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#ACDM25 has officially come to a close, and what an unforgettable journey it was! We had the pleasure of engaging with over 100 industry experts, and we’re grateful to everyone who visited our booth. John Hall captivated the audience with his fantastic session on the transformative role of ML in clinical data oversight. From automating anomaly detection to enhancing query management, his insights showed how these advancements can speed up database lock and regulatory submissions. We are so grateful for our amazing community!
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