The Importance of Risk Assessment as a Foundation of RBQM
Author: Rod Rahimi, Solution Expert at CluePoints. Risk assessment is the foundation of Risk Based Quality Management (RBQM). The adoption of statistics to assist with…
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CluePoints Appoints Andy Cooper as New Chief Executive Officer
New CEO brings a combination of experience and drive as CluePoints rapidlyscales its RBQM and Data Quality Oversight offerings King of Prussia, PA – December…
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10 reasons people like working at CluePoints
From the friendly, supportive culture to making a difference in people’s lives, there are a million and one reasons why people love working at CluePoints.…
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RBQM and ML: Perfect Partners for More Efficient Clinical Trials
Artificial intelligence (AI) and risk-based quality management (RBQM) are growing trends in pharma – and the two go together like strawberries and cream. For decades,…
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Twin Peaks: 10 years of CluePoints and Risk-Based Monitoring
It’s been ten years since CluePoints set out on a journey to let clinical trial data speak for itself – and what a journey it…
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RBQM market leader, CluePoints, marks its tenth anniversary as ICH E6 (R3) looks set to mandate the company’s data-driven approach across all clinical trials
Risk-Based Quality Management: A front row seat to a decade of transformation King of Prussia, PA – October 12th, 2022: Risk-based quality management (RBQM) solutions…
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The Inaugural ACDM AI & ML Conference Promises to Move the Dial
CluePoints is excited to participate in a brand-new annual conference designed to help the research sector level up its artificial intelligence (AI) and machine learning…
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Natural Language Processing Improves Risk Signal Documentation in Clinical Trials
Authors: Sylviane de Viron, Data and Knowledge Manager Nicolas Huet, Machine Learning Manager Central monitoring helps sponsors proactively identify quality issues in clinical trials. To…
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Federated Learning & Risk-Based Data Management – The Future of Smart Healthcare
According to CluePoints Senior Vice President John Hall, “Federated learning is a critical evolution in the application of machine learning (ML) in healthcare and clinical…
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Industry-leading Risk-Based Quality Management event focuses on the maturity of RBQM, its increasing value, and the vision for the future
CluePoints Hosts RBQM Live 2022 as the Premier Event Sponsor King of Prussia, PA – Aug 30th, 2022: Industry-leading risk-based study execution and data quality…
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The best of both: The key reasons to outsource RBQM tech but keep data control
You can outsource the work, but you can’t outsource the responsibility – so should you outsource Risk-Based Quality Management (RBQM)? It’s a question pharma companies…
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What’s in Store at the Industry’s Leading, 100% Virtual RBQM Event?
Risk-based quality management (RBQM) supports enhanced quality oversight for the entire clinical trial lifecycle, increasing the efficiency and timeliness of clinical trials and driving accelerated…
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10 Reasons Why CROs Leverage CluePoints for RBQM
Written by Andrea McSweeney, Vice President of Customer Success – Channel, CluePoints Contract research organizations (CROs) are uniquely positioned to partner with sponsors on risk…
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CluePoints to Share Case Study on Technology ROI at The SCDM 2022 EMEA Leadership Forum & Conference
Decentralized clinical trials (DCTs) have become a buzzphrase in recent years, with commentators lining up to extol the benefits of this new way of working.…
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Join us at DIA 2022 as we Demystify the De-risking of DCTs
The world of decentralized clinical trials (DCTs) and risk-based quality management is evolving rapidly – but CluePoints and our partners are here to help you…
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10 Ways the Pandemic Changed CluePoints
Author: Patrick Hughes, Co-Founder & Chief Commercial Officer, CluePoints As CluePoints celebrates ten years as the leading provider of Risk-Based Study Execution (RBx) and Risk-Based…
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10 Ways Mid-Sized BioPharma Has Applied a Pragmatic Approach to RBQM Implementation
Author: Dan Beaudry, Senior Vice President, Customer Success As the shift towards decentralized clinical trials accelerates, powered by the COVID-19 pandemic as well as the…
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Does Central Monitoring Lead to Higher Quality? An Analysis of KRI Outcomes
Author: Sylviane de Viron, Manager, Data & Knowledge, CluePoints and William Steijn, Research Data Analyst, CluePoints Central Monitoring is a key component of Risk-Based Quality…
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CluePoints Co-Founder and Chief Executive Officer to Speak at SCOPE Europe
Francois Torche, Co-Founder and Chief Executive Officer at CluePoints, will share insights into utilizing Risk-Based Quality Management (RBQM) to improve trial outcomes at this year’s…
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FDA Places Quality Management at the Heart of Updated Inspection Guide
Author: Patrick Hughes, Co-Founder & Chief Commercial Officer, CluePoints It's official: Risk-Based Quality Management (RBQM) is essential for the smooth running of clinical trials. The…
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CluePoints Wins Citeline Award for Excellence in Innovation in Response to COVID-19 – Clinical Trial Activities
Company wins prestigious accolade for contribution to Pfizer/BioNTech BNT162b2 COVID-19 vaccine development King of Prussia, PA – April 11, 2022: CluePoints, the premier provider of Risk-Based Study Execution (RBx)…
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臨床試験の分散化：障壁緩和と導入への推進
CluePoints社EMEA & APA SVP担当であるJohn Hallが、分散型臨床試験の成長を促進する市場要因と、この機会を完全に捉えるために取り除く必要のある障害について詳しく説明いたします。
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CluePoints Continues Impressive Global Growth with Three New Senior Appointments
The company welcomes new VP Marketing, VP People, and VP Business Operations to its expanding team King of Prussia, PA – April 5, 2022: CluePoints, the premier…
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Decentralized Clinical Trials: Alleviating Barriers and Driving Adoption
Author: John Hall, SVP, Business Development, EMEA & APAC John Hall, SVP, EMEA & APAC at CluePoints, discusses the market factors driving Decentralized Clinical Trial…
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10 Considerations for Small Biotechs Looking to Implement RBQM
Authors: Sophie Henderson, Customer Success Director & Nick Borders, Senior Director of Business Development Today, many clinical trial organizations realize the great benefits of Risk-Based…
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Understanding Trends in QTL Adoption
Author: Sylviane de Viron, Manager, Data & Knowledge, CluePoints The CluePoints’ Quality Tolerance Limits (QTL) module offers Sponsors and CROs a convenient way to rapidly…
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UK’s MHRA Cites CluePoints Centralized Statistical Monitoring in Updated GCP Guidance
Author: Patrick Hughes, Co-Founder & Chief Commercial Officer, CluePoints We all know that Centralized Statistical Monitoring (CSM) can vastly improve data quality and integrity in…
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UK Regulator Cites CluePoints’ Solutions in Updated Guidance
MHRA shares CluePoints case study to demonstrate the value of statistical monitoring in clinical trial oversight and monitoring King of Prussia, PA – 7th March 2022:…
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CluePoints Senior Vice President, Europe, and APAC, to Speak at SCOPE 2022
John Hall, Senior Vice President, EU, and APAC, at CluePoints, will share insights into delivering successful decentralized trials at this year’s SCOPE Conference, a Summit…
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Risk-based fraud detection: How centralized monitoring can boost data quality
Authors: Sylviane de Viron, Laura Trotta, Sebastiaan Höppner, Steve Young, Marc Buyse A new study has shown how risk-based monitoring can help detect site fraud…
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HiRO and CluePoints Partnership Offers Market-Leading RBQM Opportunities in China
King of Prussia, PA, December 13, 2021: Harvest Integrated Research Organization (HiRO), a Shanghai-based Clinical Research Organization (CRO), has collaborated with CluePoints, the premier provider…
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CluePoints Wins Scrip Award for Clinical Advance of the Year 2021
Company wins prestigious accolade for its collaboration with BioNTech and Pfizer in the Phase I/II/III study of SARS-COV-2 RNA vaccine BNT162b2 (Comirnaty)CluePoints, the premier provider…
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CluePoints SVP of Business Development to Speak at Clinical Trials Europe
John Hall, SVP Business Development at CluePoints will share insights into the dimensions of risk associated with Decentralized Clinical Trials (DCTs) at Clinical Trials Europe.…
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CluePoints Chief Scientific Officer to Speak at CNS Summit Next Month
Steve Young, Chief Scientific Officer at CluePoints, will take to the podium at this year’s CNS Summit with Lynne Cesario, Global Risk-Based Monitoring Program Lead…
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CluePoints Shortlisted for Multiple Awards in Recognition of Pioneering Risk-Based Quality Management Solution
King of Prussia, PA – October 26, 2021: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, has announced it has been…
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CluePoints Chief Scientific Officer and Pfizer’s Global RBM Program Lead to Speak at #CQOF2021
Join us at #CQOF2021! As well as hosting a booth at the Clinical Quality Oversight Forum where visitors will be able to learn about our…
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Will ICH E6 (R3) Unleash the Potential of Risk-Based Trials?
Researchers have been slow to fully adopt innovations designed to overcome the challenges to modern day clinical research, in no small part due to a…
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CluePoints Partners with ZS to Provide Best-in-Class RBQM Expertise and Technology, Increasing Clinical Trial Efficiency and Improving Patient Outcomes
August 25, 2021: CluePoints, the premier provider of Risk-Based Quality Management software for clinical trials, has partnered with ZS, a global professional services firm with technology and…
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CluePoints’ Launch Post-COVID Trial Assurance Solution
King of Prussia, PA – June 29, 2021: CluePoints, the premier provider of Risk-Based Quality Management Solutions for clinical trials, has launched a new Post-COVID Trial Assurance…
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Software Engineering Skills for a Big Societal Impact
Challenge, opportunity, fun, and the chance to make a difference – CluePoints has everything a talented software engineer is looking for. That’s according to Philippe…
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Introducing CluePoints’ Post-COVID Trial Assurance Solution
For well over a year now, the clinical research community has been hard at work to maintain progress in developing new treatments and therapies to…
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Using Risk-Based Monitoring to Focus on What Matters
Rich Davies, VP Solutions Expert at CluePoints, and Tanya du Plessis, VP Data Solutions and Strategies at Bioforum, explain how to apply the principles of…
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Revealing the Bigger Picture Through Metadata & Building RBQM Standards of the Future
Risk-Based Monitoring is the future of clinical trials – but despite significant advances in recent years, some of the practicalities of implementation need to be…
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CluePoints Sponsors RBQM Live, The Definitive Guide to RBQM for Experts and Beginners
Have you heard the news? CluePoints is sponsoring RBQM Live on behalf of the industry! The adoption of Risk-Based Quality Management (RBQM) is accelerating, and…
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Centralized Monitoring: Effective Technology & Documented Evidence are the Perfect Double Act
In the world of clinical trials, if it isn’t documented, it didn’t happen. It’s a philosophy that has informed and embedded, standardized reporting approaches into…
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CluePoints to Share COVID-Informed RBQM Best Practice at #SCOPE2021
It has never been more important for the clinical trial community to come together and share best practice – which is why CluePoints is delighted…
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Webinar: Applying the Principles of RBQM to Data Management
The planning and execution of clinical trials is on a continuous journey to leverage the benefits of risk-based approaches and Quality by Design. Regulatory guidance…
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CluePoints’ Risk-Based Quality Management Platform Instrumental in Data Quality Oversight of COVID-19 Trials
King of Prussia, PA – January 19, 2021: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials,…
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Practical Steps for Centralized Monitoring Success
The successful implementation of Centralized Monitoring requires meticulous planning, process reform and alignment, cross-functional expertise, and most importantly the right technology in place. With regulators…
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The Evolution of CluePoints’ SMART Engine
How C++ Revolutionized the Core of CluePoints With software playing an integral part of almost every device that makes daily life easier, the same is…
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CluePoints Opens New APAC Office in Tokyo
King of Prussia, PA – December 8th, 2020: CluePoints, the premier provider of Central Statistical Monitoring, Risk-Based Quality Management and Data Quality Oversight Software for…
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Life as a Clinical Data Analyst at CluePoints
Life as a clinical data analyst at CluePoints is anything but dull – so when I was asked to talk about a typical day, it…
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Best Practice Advice to Enable Teams to Focus on High Quality Data in Clinical Studies
BioPharma studies are as vast as they are pioneering, with many different teams within many different groups across many organizations all playing a part in…
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Exploring the role of AI and Machine Learning in Clinical Trials
We live in a rapidly evolving digital era shaped by a continuous stream of pioneering technological advances. The world of clinical research is no exception,…
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Centralized Monitoring – How to Unlock the Treasure Chest of Analytical Insights
Chief Scientific Officer of CluePoints, Steve Young, discusses his thoughts on how Centralized monitoring has started to take off in the clinical trials industry even…
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Applying Risk-Based Quality Management to Investigator-Led Trials
Medical science is advancing at a never before seen rate, but costs are spiralling meaning clinical trials need to change if they are to ensure…
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CluePoints Joins Forces with Global Growth Investor Summit Partners to Expand Market Leadership Position in Risk-Based Quality Management
LOUVAIN-LA-NEUVE, BELGIUM; KING OF PRUSSIA, PA; and LONDON, UK (September 1, 2020) – CluePoints S.A., a provider of Risk-Based Study Execution (RBx) and Data Quality…
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From Risk-Based Monitoring to Risk-Based Quality Management
A review of FDA marketing submissions between 2000 and 2012 revealed roughly one- third (32%) of all first-cycle review failures (16% of submissions overall) were…
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Webinar: The Future of Clinical Trial Monitoring
In the wake of COVID-19, adoption of decentralized clinical research is taking off as sponsors explore ways to maintain continuity for existing studies while looking…
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Over 300 Clinical Studies Benefit from CluePoints’ COVID-19 Risk Management Support
Addressing COVID-19 Specific Regulatory Guidance and Ensuring Early Risk Detection King of Prussia, PA – August 4th, 2020: CluePoints, the premier provider of Risk-Based…
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New Paper: From RBM to RBQM – The Future of Risk-Based Trial Management
A review of FDA marketing submissions between 2000 and 2012 revealed roughly one-third (32%) of all first-cycle review failures (16% of submissions overall) were driven…
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CluePoints & DIA Webinar: How is the Industry Coping with the Move to Remote Monitoring?
On July 28, CluePoints is teaming up with DIA for a webinar to explore how the clinical research industry is coping with the move to…
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RBQM Doesn’t have to be Complicated, Risky or Expensive: Q&A
On Wednesday, June 24, 2020, CluePoints delivered a webinar to demonstrate how using a combination of powerful analytics and comprehensive data visualization can be employed…
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CluePoints Launches Powerful Business Intelligence Platform
Personalizing the Power of Statistical Analysis and Data Visualization King of Prussia, PA – June 26, 2020: CluePoints, the premier provider of Risk-Based Study Execution…
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New Webinar: Risk-Based Quality Management Doesn’t have to be Complicated, Risky or Expensive!
Register Now for our June 24, 2020 Webinar:Risk Detection and Data Visualization Techniques that Actually Deliver on the Promise. Managing and mitigating risk, particularly in…
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CluePoints Covid-19 Support Benefits Over 200 Clinical Studies Directly Affected by the Pandemic
RISK MANAGEMENT SOLUTION ADDRESSES FDA, EMA, PMDA & MHRA CORONAVIRUS ADVICE King of Prussia, PA – May 07, 2020: CluePoints, the premier provider of Risk-Based…
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Beyond COVID-19: The New Normal in Risk-Based Monitoring (RBM) and Quality Management (RBQM)
Join our next webinar to learn first-hand how the CluePoints and Parexel partnership is driving best-in-class Risk-Based Quality Management Strategies to support clinical development. This…
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EPS Corporation Signs Groundbreaking Agreement To Drive Increased Quality And Safety Using CluePoints RBQM Solution
King of Prussia, PA – April 14, 2020: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials,…
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Early Risk Detection During the COVID-19 Crisis – Your Questions Answered
On Tuesday, March 31, 2020, CluePoints delivered a webinar centred around the critical importance of early risk detection. Our presenter also shared insights on how…
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CluePoints Launches Complimentary COVID-19 Risk Management Package for Clinical Studies
Risk Planning Guidance Addresses FDA, EMA, PMDA and MHRA Coronavirus Advice King of Prussia, PA – April 06, 2020: CluePoints, the premier provider of Risk-Based…
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Webinar Recording: The Critical Importance of Early Risk Detection with a Special Feature Addressing COVID-19
We're delighted to announce that the recording for our COVID-19 webinar has been posted! The clinical research industry is in the midst of adopting Risk-Based…
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Complimentary COVID-19 Risk Assessment Package Available To All at No Cost
As advised in the coronavirus guidances recently issued by FDA, EMA, and MHRA, it is important to perform a fresh risk assessment for each study…
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CluePoints’ Central Statistical Monitoring Supports Business Continuity as Coronavirus Impacts Clinical Trial Operations
Remote monitoring is mitigating the impact of SARS-CoV-2 on clinical trials, marking an acceleration in the adoption of modern clinical trial technologies King of Prussia,…
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Registration Open for our Risk-Based Quality Management Insights Webinar
Please join us for our March 31, 2020 webinar: RBQM Insights - Understanding the Critical Importance of Early Risk Detection (With a Special Feature Addressing…
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Risk-Based Quality Management – It’s now a Question of “how” Rather than “if”
Risk-based quality management (RBQM) solutions allow sponsors and CROs to confidently detect, and effectively manage, risk in clinical trials. It is an evidence-backed approach with…
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Implementing a Risk-Based Quality Management Strategy – The Ultimate Guide
Every organization faces unique challenges when it comes to implementing a Risk-Based Quality Management strategy. There’s no ‘one-size-fits-all’ approach that will ensure success, as each organization…
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CluePoints’ Risk-Based Quality Management (RBQM) Software Wins at Scrip Awards 2019
King of Prussia, PA – December 5, 2019: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials,…
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As Demand for RBx Soars CluePoints Continues Global Expansion Alongside Further Award Wins
KING OF PRUSSIA, PA – October 22, 2019: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials,…
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FDA Extends CRADA with CluePoints to Further Explore a Data-Driven Approach to Quality Oversight in Clinical Trials
KING OF PRUSSIA, PA, 10 September 2019– FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection…
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ICH E6 (R2) Compliance Webinar Series Available to Watch Now!
"I KNOW ICH E6 (R2) COMPLIANCE INSISTS ON A RISK-BASED APPROACH TO RUNNING MY TRIALS, BUT HOW AM I GOING TO IMPLEMENT THIS AND REALIZE…
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Parexel Strengthens Risk-Based Monitoring Offering with CluePoints’ New Advanced Statistical Capabilities
Strategic collaboration leverages CluePoints’ Central Statistical Monitoring (CSM) technology to enhance data quality and reduce operational costs. WAYNE, PA, June 18, 2019– Parexel, a leading…
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CluePoints Experiences Continued Rapid Growth as Demand for RBx Rises
WAYNE, PA – April 09, 2019: CluePoints, a leading provider of Risk-Based Study Execution(RBx) and Data Quality Oversight solutions for clinical trials, has announced a…
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Transitioning from a Risk-Based Monitoring Approach to Risk-based Quality Management
This content was originally posted on Applied Clinical Trials on March 18, 2019 One of the most significant positive changes we have seen recently is the endorsement…
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Risk-Based Study Execution (RBx) – It’s Time to Close the Loop!
When the journey started it was all about monitoring. It was about addressing the inefficiencies, rationalizing resources to reduce costs and tackle potential quality issues…
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New! Registration Open for CluePoints’ RBM Roadshows – Pick from San Francisco or La Jolla!
We’re delighted to announce that registration for CluePoints’ US Risk-Based Quality Management Roadshow is now open. Taking place in January 2019, these roadshows will provide you the opportunity to…
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Register to Participate in the CluePoints Data Quality Challenge
Are you struggling with how to assess the true value of improving data quality and integrity through Risk-Based Monitoring (RBM)? Register to participate in the CluePoints…
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Announcing the CluePoints Data Quality Challenge
Are you struggling with how to assess the true value of improving data quality and integrity through Risk-Based Monitoring (RBM)? Now is your chance to…
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The CluePoints & HighPoint Solutions Risk-Based Monitoring Roadshow Recap
The other week, CluePoints in conjunction with HighPoint Solutions delivered 3 European Roadshows in Basel, Copenhagen and Cambridge, focusing on practical, case-based methods for addressing the…
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CluePoints Strengthens Senior Team with Two Key Appointments
Wayne, PA – October 02, 2018: CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has announced the…
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Quanticate partners with CluePoints to offer Data Quality Oversight capabilities
Quanticate, a data-focused clinical research organisation (CRO), has announced that it has partnered with CluePoints to utilize their software to drive the statistical analysis to perform…
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The CluePoints & HighPoint Solutions RBM Roadshow is Coming to a City Near You!
Since the initial publication of the ICH GCP guidelines, the way clinical trials operate has changed significantly. The ICH E6 (R2) addendum, which came into effect in June…
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CluePoints Awarded Most Reputable Clinical Trial Risk-Based Monitoring Software 2018
It appears that 2018 is the year CluePoints really established itself as a leader in the industry! Having recently being honoured in the Biotechnology Awards…
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CluePoints Announces Four Year Partnership with ONO Pharmaceutical and Strengthens Risk-Based Monitoring Position in Japan
Successful pilot project prompts strategic partnership that strengthens risk-based monitoring in Japan and places both companies as leaders in their fields. Wayne, PA – CluePoints,…
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ICH E6 R2 – The Clinical R&D Industry’s Response
For decades now the complexity, cost, and duration of clinical development have been steadily increasing while profit margins for the industry have been dwindling. This…
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New Webinar Announced: Risk-Based Monitoring for All
Please join us for our upcoming webinar: Risk-Based Monitoring for All - How the ICH E6 (R2) has given clinical development organizations the perfect opportunity to…
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CluePoints Wins Best Risk-Based Monitoring Solution in 2018 Biotechnology Awards
January 31, 2018 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has been honoured…
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CluePoints Launches Risk-Based Monitoring Starter Pack to Drive Regulatory Compliance
22 January 2018 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has launched the…
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CluePoints Responds to Sponsor and CRO Demand with Two New Appointments
5 December 2017 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has announced two new…
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Beyond Risk-Based Monitoring: How Intelligent Analytics are Being Used to Drive Value and Support ICH Compliance
The complexity and size of clinical trials has increased dramatically – in parallel with growing costs and mounting regulatory pressures. The introduction of the finalized International…
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The Bigger Picture of ICH E6 R2: Looking Beyond Compliance
Journal for Clinical Studies Steve Young, Chief Operations Officer, CluePoints The introduction of ICH E6 (R2) this past year has rendered the implementation of risk-based…
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CluePoints Builds on Late Phase work in Japan and Launches Risk-Based Monitoring Roadshow in Tokyo
Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has further expanded its Late Phase…
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25% Discount Code for Partnerships in Clinical Trials 2017
We’re delighted to announce that we’ll be at Partnerships in Clinical Trials next month! You can find us at booth 120, where we’ll be showcasing…
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ICH E6 R2: Talking Big Pharma’s Response To The Addendum
This article was originally produced for Clinical Informatics News The introduction and implementation of ICH E6 R2 has raised many questions surrounding operational risk-based approaches to…
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CluePoints V1.12.0 is Live!
Today, we’re excited to announce that we’ve added an abundance of new features to the CluePoints Central Monitoring platform. From out-of-the-box integration for data sources…
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Eight Reasons Why You Need to Attend CBI’s Global Risk-Based Monitoring Event
This month, experts from across the globe will gather for CBI’s Global Risk-Based Monitoring event, taking place on September 14-15. If you haven’t decided if you’re attending…
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Explore the ICH E6 Rev2 at Outsourcing in Clinical Trials New England
Arena International’s flagship event, Outsourcing in Clinical Trials New England, is almost upon us. This year’s edition, taking place on September 6-7, 2017, at The…
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ICH E6 R2 Roundtable Review – What Does This Mean for the Industry?
The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry.…
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ICH E6 R2: Waiting and Watching no Longer an Option When it Comes to Risk-Based Monitoring
As is typical of our industry, despite ringing endorsements of Risk-Based Monitoring (RBM) from both the FDA and EMA back in 2013, researchers have been…
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CluePoints Opens U.S. Office
2 May 2017 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, today announced that…
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CluePoints’ Founder to Present on Risk-Based Monitoring at FDA/AdvaMed Conference
The 10th Annual FDA/ADVAMED Medical Devices and Diagnostics Statistical Issues Conference, taking place on April 26, 2017 to April 27, 2017, brings together leading authorities…
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ICH E6 (R2) – Miracle Pill for the Clinical R&D Industry
ACRP Clinical Researcher ICH E6 R2 – Miracle Pill for the Clinical R&D Industry Steve Young, Chief Operations Officer, CluePoints Publication of the long-awaited ICH…
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ICH E6 Rev 2 – Ask the Experts
Last week, we hosted our second webinar of 2017, Implementing Risk-Based Monitoring – What Does the ICH E6 Rev 2 Mean for My Company? There…
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Webinar Recording: What Does ICH E6 R2 Mean for Me and My Company?
This week, CluePoints hosted a webinar with Paragon Solutions, which was geared towards preparing attendees on how to take advantage of the ICH E6 revisions…
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CluePoints Launches Patient Profiles as Latest Addition to its Risk-Based Monitoring and Data Quality Oversight Solution
13 March 2017 Cambridge, MA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has introduced Patient…
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CluePoints COO, Steve Young, to Present on Statistical Probability Analysis at MCC’s Central Monitoring Workgroup
The Central Monitoring Workgroup will feature speakers from several solution providers who will each present and discuss the types of analytic methods that are relevant…
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Patient Profiles unveiled as latest addition to CluePoints’ Risk-Based Monitoring and Data Quality Oversight solution
We’re thrilled to announce that version 1.11.0 of CluePoints’ Central Monitoring platform, the enabling SaaS platform for Risk-Based Monitoring, will be available to users in…
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6th Annual CROWN Congress: Sessions you Can’t Afford to Miss + 15% Discount Code
It’s really no secret that the evolving regulatory landscape for clinical trials is a hot topic amongst the community. Just take a look at the agenda…
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Six Ways to Get the Most out of Outsourcing in Clinical Trials West Coast ‘17
There’s only a couple of weeks to go until Arena’s flagship event, Outsourcing in Clinical Trials West Coast returns to Burlingame. The must-attend event brings…
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CluePoints’ Risk-Based Monitoring Solution Receives Clinical Informatics News Best Practices Award
Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring solutions for clinical trials, today announced that it has won a Clinical Informatics News Best…
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The FDA is Knocking at your Door – Are you Ready for an FDA Site Inspection?
Are you ready for an FDA site inspection? You may have heard that CluePoints signed an agreement with the FDA. This Cooperative Research and Development…
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Webinar: Risk-Based Monitoring Implementation – What does ICH E6 Rev2 Mean for My Company?
With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to…
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CluePoints – Finalists in The Clinical Informatics News 2017 Best Practices Awards at SCOPE, Jan 24th – 26th in Miami
We’re thrilled to announce that CluePoints has been named as finalists for the Clinical Informatics News 2017 Best Practices Awards, for our award-winning Risk-Based Monitoring…
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CluePoints CEO, Francois Torche, to Present at SCOPE Summit for Clinical Ops Executives
The 8th Annual SCOPE Summit for Clinical Ops Executives, taking place on January 24-26, 2017 in Miami, FL, will offer three stimulating days of in-depth…
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CluePoints Partners with Metrics Champion Consortium to Define Metrics and Standards for Centralized Monitoring
8 November 2016 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) and Risk-Based Monitoring(RBM) solutions for clinical trials, announces its partnership with…
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CluePoints Introduces Data Quality Oversight Service for Site Inspection Readiness
31 October 2016 Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced…
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FDA Signs Agreement with CluePoints to Explore a Data-Driven Approach to Quality Oversight in Clinical Trials
12 October 2016 Cambridge, MA - FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of…
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CluePoints Teams up with Paragon Solutions to Share the Secrets of Successful Risk-Based Monitoring Implementation
We’re delighted to announce that are our next Risk-Based Monitoring implementation webinar is open for registration! Register now – this is THE Risk-Based Monitoring webinar…
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CluePoints Announces Locations for Risk-Based Monitoring Implementation Roadshows
The CluePoints and OmniComm Risk-Based Monitoring Implementation Roadshow is Coming to a City Near You! In response to the rising complexity and cost of clinical…
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CluePoints Answers your Risk-Based Monitoring Implementation Questions
Q1) Are the indicators percentages? E.g., % AEs for the site v study or just number (which could indicate that there are many AEs as…
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CluePoints Announces Free Risk-Based Monitoring Strategy Review
We’re thrilled to announce that CluePoints is now offering a complimentary Risk-Based Monitoring strategy Check-up and Risk Management review, aimed at helping sponsors and CROs accelerate their…
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Risk-Based Monitoring Insights from the Industry: Angie Maurer
Part Seven In the latest of our eight-part ‘Insights from the Industry’ series, we caught up with Angie Maurer, Co-Founder & CEO at Zynapsys. Here’s what…
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CluePoints Appoints Steve Young as Senior Vice President of US Operations
16 August, 2016 Cambridge, MA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has appointed Steve…
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CluePoints CEO, François Torche, Honored in PharmaVOICE 100
1 August 2016 Cambridge, MA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has today announced that its CEO, François…
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CluePoints Risk-Based Monitoring Platform (Version 1.9.0) is Live!
We’re thrilled to announce that CluePoints’ latest version (1.9.0) of the Central Monitoring platform is live! Version 1.9.0 adds an abundance of new features (as requested by…
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CluePoints Founder, Marc Buyse to Deliver Clinical Trial Data Quality Course at the ASA Biopharmaceutical Workshop
The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is fast approaching and we’re thrilled to announce that CluePoints Founder, Marc Buyse will deliver a course with…
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Risk-Based Monitoring Insights from the Industry: Jamie O’Keefe
Part Six In the latest of our eight-part Q&A series, we catch up with Jamie O’Keefe, Vice President, Life Sciences, and R&D Practice at Paragon Solutions to…
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Is Risk-Based Monitoring the Answer to Data Quality Issues?
It’s no secret that data quality is at the heart of every clinical trial. Data validation is one of the main objectives in the FDA’s…
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Risk-Based Monitoring Insights from the Industry: Steve Young
Part Five We’ve heard some great insights on the current hot topics in Risk-Based Monitoring (RBM) from a number of leading experts over recent weeks.…
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Defining Clinical Trial Thresholds: Objective Vs Subjective?
Over the past few weeks, we’ve been discussing the thoughts of some of the leading experts in Risk-Based Monitoring, and we’ve really appreciated those of…
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Central Statistical Monitoring Should Support Key Risk Indicators
As you may well know, much of the early work in Risk-Based Monitoring has focused on relatively simple Key Risk Indicators (KRIs) and traffic-light dashboards,…
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Are the Regulatory Authorities Ready for the Adoption of Risk-Based Monitoring?
Firstly, thanks to those of you who got involved with our recent discussion about current best practice in Risk-Based Monitoring, it was great to hear…
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Risk-Based Monitoring Insights from the Industry: Dr. Peter Schiemann
In the fourth installment of the CluePoints Risk-Based Monitoring Q&A series, we spoke to Dr. Peter Schiemann, Managing Partner and Co-Founder of Widler & Schiemann, who…
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How will Risk-Based Monitoring Coexist with other Clinical Trial Technology?
We’ve been really enjoying hearing your thoughts on the latest Risk-Based Monitoring hot topics over the last few weeks, so thank you to everyone who…
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Risk-Based Monitoring Insights from the Industry: Karen Fanouillere
Part Three In the third of an eight-part Q&A series which aims to explore some of the current hot topics in Risk-Based Monitoring (RBM), CluePoints…
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Unveiling CluePoints’ New and Improved Risk-Based Monitoring Software
Today, we’re thrilled to unveil CluePoints’ latest release of its award-winning Risk-Based Monitoring Software. For this release, we wanted to hone in on several customer…
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Risk-Based Monitoring Insights and Strategies from the Industry: Adam Butler
Part Two Recently, CluePoints has been taking time out with some of our valued partners to discuss hot topics in Risk-Based Monitoring (RBM). Here, in…
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Is it too soon to Define Best Practice When it Comes to the Practical Implementation of Risk-Based Monitoring?
Last week CluePoints launched its eight-part Q&A blog series which aims to explore the current talking points in Risk-Based Monitoring (RBM). We’ve been gathering insights…
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Risk-Based Monitoring Insights from the Industry: Craig Serra
Part One In the first of an eight-part Q&A series which aims to explore some of the current hot topics in Risk-Based Monitoring (RBM), CluePoints…
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CluePoints Announce 2nd Annual Risk-Based Monitoring Roadshows to take place in Basel, Switzerland & Cambridge, UK
Join CluePoints CEO Francois Torche and OmniComm Sr. Director Steve Young at this special thought leadership event where you will hear about the benefits derived from an integrated…
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CluePoints Named Clinical Research & Excellence Awards Finalist
Awards recognize CluePoints’ Risk-Based Monitoring solution in the ‘Best Sponsor-Focused Technological Development’ category Cambridge, MA - CluePoints, a leading software provider of Risk-Based Monitoring (RBM)…
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RACT clinical Trials: How to Deploy Risk Assessment Categorization Effectively
The move towards risk-based monitoring promises to bring clinical trials into the 21st century by driving the efficient delivery of life-changing new medicines. But while…
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Transcelerate’s Latest Paper – “Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations”
Pressure is growing for sponsors to implement robust controls to identify data quality issues that may impact trial outcomes, and this is understandable given the…
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CluePoints and Widler & Schiemann Collaborate on Complete Risk-Management Solution for Clinical Trials in Line with New Industry Guidance
Partnership will combine CluePoints' Risk-Based Monitoring Software with Widler & Schiemann's Consultancy Services 2 November 2015 Cambridge, MA - CluePoints, a leading software provider of…
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CluePoints Partners with OmniComm Systems® to Offer Collective Risk-Based Monitoring & Electronic Data Capture Solution
Strategic collaboration enables customers to harness the value of data capture coupled with data quality oversight 20 October 2015 Cambridge, MA - CluePoints, a leading…
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CluePoints Announces Partnership with Bracket for CNS Trials
Strategic partnership will bring together CluePoints' Risk-Based Monitoring Software with Bracket's Rater Training and Quality Assurance Services for CNS trials 6 October 2015 Cambridge, MA…
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CluePoints Chief Commercial Officer Named in PharmaVOICE 100
3 August 2015 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has today announced that its Chief…
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CluePoints Receives € 6million Growth Investment
Funding will grow both operations and business development in the U.S 23 July 2015 Cambridge, MA - CluePoints, a leading software provider of risk-based monitoring…
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Risk-Based Monitoring Software for Operational Data Analysis
15 June 2015 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today introduced software to enable analyses…
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CluePoints Announces U.S Patent Allowance for SMART™ Engine
18 May 2015 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced that the United States…
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CluePoints’ CSM Solution with Oracle Health Sciences Cloud Can Enable Proactive RBM and Improve Data Quality
Combined solution can help identify trial risks in operational and clinical data before traditional methods 22 April 2015 Cambridge, MA - CluePoints, a leading provider…
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CluePoints and ACRES Partner to Improve Data Quality in Clinical Research
CluePoints and the Alliance for Clinical Research Excellence and Safety (ACRES) announce a strategic agreement to join forces in identifying potential risks to the quality…
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CluePoints SaaS Solution Demonstrates Improved Data Integrity & Quality by Putting Sponsors in Control of Risk-Based Monitoring
Central Statistical Monitoring solution tested by sponsors for ability to independently detect & interrogate anomalies in clinical trial data 12 January 2015 Cambridge, MA…
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CluePoints Wins Award for Best Technological Development in Clinical Trials
Company wins prestigious accolade for its Risk-Based Monitoring Software at the 2014 Scrip Awards We are delighted to announce that CluePoints won the Scrip Award…
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CluePoints Wins ENTENTE Life Science Investment Forum Award
Win marks second award for CluePoints this month 9 December 2014 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials,…
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CluePoints Used to Checked Data Quality in Large Phase III Gastric Cancer Trial
CluePoints selected by the Nagoya University School of Medicine to assess data quality and integrity 16 September 2014 Cambridge, MA - CluePoints, a leading provider…
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Want Full Control of Your Risk-Based Monitoring Analyses?
CluePoints introduces a web-based Central Statistical Monitoring (CSM) SaaS solution As you may have read on a few industry blogs, we recently launched a Software-as-a-Service…
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CluePoints Strengthens and Expands Global Team in Growing Risk-Based Monitoring Market
Company announces new board and business development appointments 25th February 2014 Cambridge, MA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for clinical…
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EMA Guidance Points to Central Statistical Monitoring
While capable of conducting high-quality trials, the current oversight process can be expensive and inefficient. February 1, 2014 By Marc Buyse, ScD Read the article…
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The Evolution of CluePoints’ SMART Engine
Regarding CluePoints' statistical approach to risk-based monitoring in clinical trials, we are often asked questions about sample size, such as: "How many subjects are needed per site…
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CluePoints’ Commentary – EMA Reflection Paper on Risk Based Quality Management in Clinical Trials
The final version of the EMA Reflection Paper on Risk Based Quality Management in Clinical Trials is now available. This document, as well as the…
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A CluePoints Case Study: Confirmation of Fraud – Diaries Completed by Staff
In a phase III trial in vascular disease, over 4,500 patients were randomized across 160 sites. The CRF included 480 variables for 32 domains. The…
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Risk-Based Management and the Difference Between Key Risk Indicators and Central Statistical Monitoring
ClueBot here! Did you miss me? I’ve actually dropped by to share some exciting news. A few months ago, my wonderful creator at CluePoints, Dr…
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CluePoints Cited in New FDA Guidance
12 August 2013 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that its CSM techniques…
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New FDA Guidance Encourages Sponsors to Use Centralized Statistical Monitoring for Improved Data Quality
https://www.youtube.com/watch?v=1pxNwHQiFNY&feature=youtu.be Background The recent release of the final guidance document detailing the FDA’s stance on the “Oversight of Clinical Investigations” is welcome news for the…
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