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Latest Industry Updates

From company milestones to industry breakthroughs, uncover the stories making waves and shaping the narrative in real time.

Predictions for the Future of Risk-Based Quality Management (RBQM)
Regulatory changes, including the launch of ICH E6(R3) and Good Clinical Practice (GCP) updates, have...
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Today Discover Pharma launches its annual 12 Days of Christmas campaign featuring CluePoints insight on RBQM
Sophie Henderson, Senior Strategic Consultant at CluePoints, said: “This year we have seen risk-based...
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CluePoints Scoops Prestigious 2025 Scrip Award
CluePoints Scoops Prestigious 2025 Scrip Award RBQM and AI leader wins the ‘Best Contract Research Organization...
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CluePoints Data and Knowledge Manager Appointed to ACT Editorial Advisory Board
King of Prussia, PA – November 5th, 2025: CluePoints, provider of leading statistical and AI-driven software...
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The Modern CRA: Operationalizing Data-Driven Site Success
As clinical trials become more complex, leading sponsors are shifting the focus of their clinical research...
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KRI Overload: When More Isn’t Better
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CluePoints Brand Evolution Confirms Commitment to ‘Turning Artificial Intelligence into Human Intelligence’

KING OF PRUSSIA, Pa., — CluePoints, provider of leading statistical and AI-driven software solutions, today unveiled...

Quality Tolerance Limits: An Updated View of Industry Trends

We presented an initial review of quality tolerance limit (QTL) adoption trends in the March 2023...

Source: Applied Clinical Trials

FDA And CluePoints Sign New 3 Year Cooperative Research And Development Agreement To Assess Data Quality Using Statistical Modelling And Machine Learning

King of Prussia, PA: CluePoints, providers of leading statistical and AI-driven software solutions and Food and...

FDA and CluePoints Extend Existing Collaboration to Include AI/ML for Quality Assessment

Under the new extension, FDA and CluePoints will enhance CluePoints’ SMART software to address a broader...

Source: Applied Clinical Trials

The Risk-Based Data Management (RBDM) Revolution

The clinical trials landscape is evolving with more data, increased investment in personalized medicines and a...

Source: Clinical Research News

Leveraging Machine Learning and Deep Learning for Natural Language Processing in Clinical Data Management

Nicolas Huet, CluePoints Machine Learning Manager, discusses developments in the use of machine learning and deep...

Source: Pharmaceutical Outsourcing

The Future of RBQM Adoption

In the fifth and final part of this video interview series, Ken Getz, executive director and...

Source: Applied Clinical Trials

Potential Pitfalls Without RBQM Adoption

In part 4 of this video interview series, Ken Getz, executive director and research professor, Tufts...

Source: Applied Clinical Trials

Increasing Comfortability With Adopting Risk-Based Approaches

In part 3 of this video interview series, Ken Getz, executive director and research professor, Tufts...

Source: Applied Clinical Trials

Ken Getz of Tufts CSDD and Steve Young of CluePoints Discuss Stand Out Results from Recent RBQM Study

In part 2 of this video interview series, Ken Getz, executive director and research professor, Tufts...

Source: Applied Clinical Trials

Ken Getz of Tufts CSDD Discusses RBQM Study Conducted with CluePoints and PwC

In part 1 of this video interview series with Ken Getz, executive director and research professor,...

Source: Applied Clinical Trials

Clinical Research 2.0 Must Embrace Change

We are at a tipping point in the adoption of Clinical Research 2.0. The evolution of...

Source: PM360

CluePoints Wins Scrip Award for Clinical Advance of the Year 2021

CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical...

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...

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...

CluePoints Shortlisted for Multiple Awards in Recognition of Pioneering Risk-Based Quality Management Solution

King of Prussia, PA: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality...

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...

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...

CluePoints Partners With ZS To Provide Best-In-Class RBQM Expertise And Technology, Increasing Clinical Trial Efficiency And Improving Patient Outcomes

CluePoints, the premier provider of Risk-Based Quality Management software for clinical trials, has partnered with ZS,...

Introducing CluePoints’ Post-COVID Trial Assurance Solution

For well over a year now, the clinical research community has been hard at work to...

Revealing The Bigger Picture Through Metadata & Building RBQM Standards Of The Future

Risk-Based Monitoring (RBM) is the future of clinical trials. Yet, despite significant progress in recent years,...

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...

Centralized Monitoring: Effective Technology & Documented Evidence Are The Perfect Double Act

If it isn’t documented, it didn’t happen. This mindset has shaped the way clinical monitoring activities,...

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...

Why Risk-Based Quality Management Represents the Future of Clinical Research

By empowering researchers to detect data quality issues in real-time, Risk-Based Quality Management (RBQM) and Risk-Based...

Source: Journal for Clinical Studies

Managing Clinical Trials Amid the Coronavirus Pandemic

Amid the ongoing Coronavirus pandemic, clinical trial sites are increasingly inaccessible for patients and site staff,...

Source: Tufts Center for the Study of Drug Development

Effective Risk Management When Using eCOA and ePRO

The use of direct source data capture in clinical research is on the rise, both during...

Source: Clinical Research News

Leveraging Audit Trails to Monitor Clinical Study Risk

The clinical research industry has gone through an important transformation over the past 15 to 20...

Source: ACRP

Using Statistics to Improve Data Quality and Maximize Trial Success

Poor quality data has the potential to destroy the validity of a clinical trial, wasting precious...

Source: Tufts Center for the Study of Drug Development

How ICH E6 (R2) Provides a Win/Win/Win through Risk-Based Study Execution

Participant safety is the clinical trial sector’s top priority – and striving to achieve this laudable...

Source: Applied Clinical Trials

From RBM to RBx: The Keys to Successful Adoption and Implementation

The latest version of the Good Clinical Practice (GCP) quality standard insists that sponsors implement a...

Source: Global Forum

Detection of Atypical Data in Multicenter Clinical Trials Using Unsupervised Statistical Monitoring

A risk-based approach to clinical research may include a central statistical assessment of data quality.

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Source: Sage Journals

Leveraging Intelligent Analytics to Realize the Full Value of RBx and Compliance with ICH E6 (R2)

Not only is there a significant good clinical practice (GCP) expectation, Risk-Based Monitoring (RBM) presents a...

Source: Contract Pharma

FDA Offers Further RBM Guidance Stressing Data Quality Oversight

Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a...

Source: Outsourcing Pharma

How SMEs Can Achieve Regulatory Compliance Through a Risk-Based Approach

Since the introduction of the ICH E6 (R2) addendum, the industry has seen a rise in...

Source: Pharma Focus Asia

Update on ICH E6 (R2) Guideline for GCP

The ICH E6 R2 Addendum is starting to have a significant, positive impact on clinical trial...

Source: Contract Pharma