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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.

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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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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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  • Featured Article
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

  • Press Release
CluePoints’ Risk-Based Quality Management (RBQM) Software Wins At Scrip Awards 2019

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

  • Featured Article
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

  • Press Release
As Demand For RBx Soars CluePoints Continues Global Expansion Alongside Further Award Wins

KING OF PRUSSIA, PA: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality...

  • Featured Article
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

  • Press Release
FDA Extends CRADA With CluePoints To Further Explore A Data-Driven Approach To Quality Oversight In Clinical Trials

KING OF PRUSSIA, PA– FDA and its stakeholders have an interest in assuring the integrity of...

  • Featured Article
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

  • Press Release
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...

  • Featured Article
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.

...

Source: Sage Journals

  • Press Release
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...

  • Featured Article
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

  • Press Release
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...

  • Press Release
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...

  • Press Release
CluePoints Scoops Prestigious 2025 Scrip Award

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

  • Press Release
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...

  • Press Release
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...

  • Press Release
CluePoints Sponsored RBQMLive Returns for 2025

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

  • Press Release
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...

  • Press Release
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...

  • Press Release
CluePoints named as Finalist in 2025 ACDM Awards

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

  • Press Release
CluePoints Appoints Richard Young as Chief Strategy Officer

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

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Featured Article
DIA Global Forum: Statistics Powering Risk-Based Quality Management

CluePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical...

Source: DIA

  • Featured Article
Solving the Rubik’s Cube of Competing Forces to Realize the Future of Clinical Research

Artificial intelligence (AI) has massive potential to advance clinical research.

...

Source: DIA

  • Featured Article
DIA 2023 Topic: The Industry-Wide Definition for RBQM

At the recent DIA 2023 Global Annual Conference, I focused my attention on discussions about the...

Source: Clinical Research News

  • Featured Article
Statistics Powering Risk-Based Quality Management

CluePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical...

Source: DIA

  • Featured Article
RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)

A conversation with Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts...

Source: Clinical Leader

  • Featured Article
Women in Pharma 2023 | Growing Leadership and Choosing Your Priorities

The pharmaceutical industry has a problem – a failure to provide women with C-suite opportunities.

...

Source: International Clinical Trials

  • Featured Article
ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?

The ICH E6(R3) draft guideline document, currently open to public consultation, places the industry firmly in...

Source: Applied Clinical Trials

  • Featured Article
RBQM Elements Have Seen Limited Adoption in Trials, New Global Survey Finds

Despite the push for greater use of risk-based quality management (RBQM) in clinical research, adoption of...

Source: CenterWatch

  • Featured Article
Industry Trends: Cycle Time to Resolve Risk Signals

Central monitoring aims to detect emerging quality-related risks proactively during a clinical trial, resulting in study...

Source: Applied Clinical Trials

  • Featured Article
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

  • Featured Article
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...

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Source: Springer Link

  • Featured Article
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

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