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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.

How agentic AI is shifting data management from time-consuming investigation to confident confirmation
AI is reshaping clinical data management (DM), moving the industry away from time-consuming, inefficient...
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How AI and Advanced Statistics Are Helping Research Rise
Clinical trials are undergoing a period of change. Innovative uses of artificial intelligence (AI) are...
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Safety Reporting in RBQM: Bridging Risk Assessment, Monitoring, and Action
Safety reporting is a critical aspect of clinical trial quality, directly impacting patient safety and...
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Is Agentic AI The ‘Next Leap Forward’ for Clinical Trial Data Management?
In clinical trials, every second counts, both for patient outcomes and sponsor ROI. As data volumes grow...
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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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Six geese a-laying: CluePoints’ AI predictions for 2026

Returning to the series is CluePoints, with Sophie Henderson, senior strategic consultant, sharing her hopes and...

Source: Discover Pharma

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 highlighted...

Source: International Pharmaceutical Industry

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 quality management...

Source: Discover Pharma

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...

The Modern CRA: Operationalizing Data-Driven Site Success

As clinical trials become more complex, leading sponsors are shifting the focus of their clinical research...

Source: The Association of Clinical Research Professionals

KRI Overload: When More Isn’t Better

Source: Applied Clinical Trials

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...

Using AI and Advanced Analytics to Transform Clinical Trials

Ken McFarlane of CluePoints shares insight on better, smarter ways to detect risk, streamline data review,...

Source: Contract Pharma

Reactions to Being “Powered By Purpose” on Clinical Trials Day 2025

As a follow-up to Clinical Trials Day 2025, held on May 20 with the theme of...

Source: The Association of Clinical Research Professionals

Detecting Fraud in Clinical Trials Using Statistical Data Monitoring

“Identifying … potential data manipulation and data integrity problems” are an International Council for Harmonization of...

Source: Applied Clinical Trials

HiRO and CluePoints Partnership Offers Market-Leading RBQM Opportunities in China

King of Prussia, PA: Harvest Integrated Research Organization (HiRO), a Shanghai-based Clinical Research Organization (CRO), has...

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,...

The Role of KRIs in Process-Driven RBQM Success

Using key risk indicators (KRIs) can improve clinical trial data quality in 80% of the sites...

Source: Applied Clinical Trials

Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters

Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and...

Source: Springer Link

Quality Tolerance Limits: A Review of Industry Trends

An expectation for the use of quality tolerance limits (QTLs) was formally established in the International...

Source: Applied Clinical Trials

The Role of Transferable Skills and Data Science in the Move to Digitally-Enabled Clinical Research

Clinical research is evolving rapidly, with the digitalization of trials creating a new modus operandi and...

Source: Applied Clinical Trials

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