CluePoints

🏆 Congratulations to our 2025 CluePoints Champions! 🏆 At the 2025 CluePoints Annual Ignyte, we had the privilege of recognizing two outstanding individuals who embody the values that drive CluePoints forward. The CluePoints Champion Awards celebrate those who push boundaries, overcome challenges, and make a lasting impact in the industry. 🎉 Lynne Cesario – Executive Director, Global Risk-Based Monitoring Program Lead, Pfizer 🎉 Cris McDavid – Senior Director, Global Clinical Operations, Parexel These leaders exemplify innovation, strategic thinking, and advocacy, inspiring change in clinical trials and beyond. Thank you, Lynne and Cris, for your contributions to advancing risk-based quality management! Join us in celebrating their achievements! 👏 #CluePoints #Ignyte25 #ChampionAwards #RBQM #ClinicalTrials

Exciting news from Washington, DC! The 2025 CluePoints Annual Ignyte meeting is in full swing, and we’re thrilled to connect with our vibrant community and industry leaders. Get ready to explore our latest innovations, dive into ICH E6 R3 updates, and most importantly, hear from YOU—our valued clients and how they are leveraging CluePoints in clinical trials. Let’s make these next few days unforgettable! 💡

Letting the stats do the talking...

With the rise of ePROs, wearables, and telemedicine, DCTs are transforming how we collect and analyze data. But do you truly have full visibility across large-scale trials? 🕵️♀️ Join Laura Trotta, VP of Research, for an exclusive webinar on Wednesday, March 26th, at 10:00 AM ET. Laura will dive deep into risk detection and quality management, equipping you with the essential strategies to get ahead of DCT risks. Register today: https://hubs.ly/Q03804c60 #Decentralization #DCT #AuditTrailReview #RiskDetection

Not all sites need the same level of oversight. Some run smoothly, while others pose high-risk challenges—but with so much data, spotting the difference isn’t always easy. That’s where adaptive site monitoring comes in. Download our guide to learn how to identify high-risk sites early before issues escalate, move beyond rigid schedules, and optimize resources without sacrificing quality or compliance. Smarter site monitoring starts here. 📖 Grab your free copy now: https://hubs.ly/Q03chY100

💡 Big questions demand big conversations. Join CluePoints for a unique opportunity to network with top minds in clinical research, gain valuable insights, and get an in-depth look at our Product Roadmap. Arriving early? Kick things off at our Welcome Reception tonight. Register now: https://cvent.me/QVxB7R 📅 Wednesday & Thursday, March 19-20, 2025 ⏰ 9:00 AM ET 🌎 Westin Georgetown, Washington, D.C. 🍸 Welcome Reception: March 18, 7:00 – 9:00 PM ET #RBQM #ClinicalTrials #ClinicalResearch #DataScience

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

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

🎉 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! 🥧

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