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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.

When Women Thrive, We all Rise
The theme for this year’s International Women’s Day (IWD) on 8th March was ‘Give to Gain’. The campaign...
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Quality Tolerance Limits: Why Breaches Happen Early and How to Act Fast
Quality tolerance limits (QTLs) are trial-level thresholds on critical-to-quality (CtQ) factors—key measures...
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Transitioning to risk-based clinical trial management under ICH E6(R3)
Risk-based quality management (RBQM) is becoming central to clinical trial oversight, with ICH E6(R3)...
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A Signal Isn’t Resolved Until It Stays Closed—RBQM Lessons
Analysis of more than 880 clinical trials shows that while statistical data monitoring and key risk indicator...
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CluePoints Appoints New Chief People Officer to Support Next Phase of Global Growth
King of Prussia, PA – January 12, 2026 – CluePoints, provider of leading statistical and AI-driven software...
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PharmaVoice’s Crystal Ball: What’s next for AI and drug R&D
As AI finds solid footing in pharma R&D, the technology is slated to yield significant rewards. Industry...
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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’ Site Profile & Oversight Tool (SPOT) shortlisted as finalist in 2024 Citeline Awards

King of Prussia, PA – March 25, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

Scope of Industry Risk-Based Quality Management (RBQM) Adoption Revealed

King of Prussia, PA: A comprehensive assessment of risk-based quality management (RBQM) adoption has revealed that...

CluePoints’ Audit Trail Review Project Wins Award for Innovation in the Management of Clinical Data Award

King of Prussia, PA – March 5, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

CluePoints Appoints New Chief People Officer to Support Next Phase of Global Growth

King of Prussia, PA – January 12, 2026 – CluePoints, provider of leading statistical and AI-driven...

CluePoints Scoops Prestigious 2025 Scrip Award

CluePoints Scoops Prestigious 2025 Scrip Award RBQM and AI leader wins the ‘Best Contract Research Organization...

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...

CluePoints Proven AI Innovation Earns Dual Recognition at SCDM and SCRIP Awards

The RBQM and AI leader wins the ‘Clinical Data Science Implementation Excellence Award’ at SCDM 2025...

CluePoints Sponsored RBQMLive Returns for 2025

KING OF PRUSSIA, Pa., Sept. 23, 2025 /PRNewswire/ — CluePoints, the premier sponsor of RBQMLive and...

CluePoints’ Technology Named as Finalist in 2025 Citeline Awards

RBQM and AI leader was shortlisted for its Time Similarity Test in the ‘Innovative Clinical Trial...

CluePoints Appoints Usama Dar as Chief Product and Technology Officer

King of Prussia, PA – April 1st, 2025: CluePoints, provider of leading statistical and AI-driven software...

CluePoints named as Finalist in 2025 ACDM Awards

The Company, along with its Research and Development Teams, were shortlisted for continuing its mission of...

CluePoints Appoints Richard Young as Chief Strategy Officer

CluePoints Appoints Richard Young as Chief Strategy Officer King of Prussia, PA – October 28th, 2024:...

CluePoints Wins Growth Award at BVA Private Equity Awards

King of Prussia, PA – October 23rd, 2024: CluePoints, provider of leading statistical and AI-driven software...

CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review

CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency with this latest...

CluePoints Continues ‘Turning Artificial Intelligence into Human Intelligence’ by Launching Two New Innovations

Site Profile & Oversight Tool (SPOT) and Intelligent Medical Coding (IMC) unveiled by RBQM innovator at...

The Eradication of False Signals in Monitoring

Risk-based approaches to monitoring clinical trials were brought to the forefront with an FDA guidance published...

Source: Applied Clinical Trials

Identifying Important Risk Indicators in Clinical Development

Key risk indicators (KRIs) are metrics designed to identify risks of specific interest to study teams...

Source: Applied Clinical Trials

RBQM: A Natural Evolution to Achieve Gold Standard Clinical Trial Management (Pages 38-39)

The success of clinical development programmes, drug approval and marketing depends ultimately on the readability and...

Source: International Clinical Trials

Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes

Central monitoring, which typically includes the use of key risk indicators (KRIs), aims at improving the...

Source: Springer Link

Causing a Wave of New Career Opportunities

Clinical research is in the grips of a revolution that has caused a wave of new...

Source: ACRP

Achieving Successful Decentralized Trials by Leveraging RBQM and Centralized Monitoring Oversight

Virtual or decentralized clinical trials present a far more patient-centric approach to conducting clinical research, building...

Source: Applied Clinical Trials

Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring

A central statistical assessment of the quality of data collected in clinical trials can improve the...

Source: National Library of Medicine

Unlocking the Potential of Risk-Based Quality Monitoring

Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) are shifting the clinical research landscape, dramatically accelerating...

Source: Applied Clinical Trials

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