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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.

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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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!...

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...

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...

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...

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 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 Cambridge, MA –...

CluePoints Partners with OmniComm Systems® to Offer Collective Risk-Based Monitoring & Electronic Data Capture Solution

Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials,...

CluePoints Announces Partnership with Bracket for CNS Trials

Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials,...

CluePoints Chief Commercial Officer Named in PharmaVOICE 100

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials,...

CluePoints Receives € 6million Growth Investment

Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials,...

Risk-Based Monitoring Software for Operational Data Analysis

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials,...

CluePoints Announces U.S Patent Allowance for SMART™ Engine

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials,...

CluePoints, a Leading Provider of AI-Driven Software Solutions for Clinical Data Review, Receives Significant Investment for Continued Growth from EQT

CluePoints is a cloud-based software platform for Risk-Based Quality Management (“RBQM”) and data quality oversight in...

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...

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...

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...

Game-Changing ‘Audit Trail Review’ Application Secures ACDM 2024 Awards Nomination for CluePoints

King of Prussia, PA – February 6, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

CluePoints wins SCRIP Awards for Best Contract Research Organization (CRO): Specialist Providers

King of Prussia, PA – October 17, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

Pioneering AI solutions and a commitment to industry-wide RBQM advancement secures CluePoints a finalist position in the 2023 SCRIP Awards

King of Prussia, PA – October 12, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

RBQMLive, Sponsored by CluePoints, Wins Prestigious Sales and Marketing Award

King of Prussia, PA – August 9, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

Expert Speaker Lineup Revealed for Award Winning RBQM Event

King of Prussia, PA – August 1, 2023: CluePoints, the premier provider of Risk-Based Quality Management...

CluePoints, Ken Getz & Tufts CSDD and PwC Unveil New RBQM Insights Report at DIA Global Annual Meeting 2023

King of Prussia, PA – June 20, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

Risk Planning: A Review of Industry Trends

An essential component of risk-based quality management (RBQM), as detailed in both the ICH E8 (R1)...

Source: Applied Clinical Trials

Achieving Optimal Adoption of Risk-Based Quality Management

The need to boost education, shift culture, and embrace new technologies.

...

Source: Applied Clinical Trials

The Negative Impact of Failing to Implement Risk-Based Quality Management

As an industry, we regularly discuss the benefits of adopting risk-based quality management (RBQM). The good...

Source: International Clinical Trials/European Pharmaceutical Contractors

There’s No Such Thing as Too Much Data

François Torche dispels the myth that, at least in RBQM, there is such a thing as...

Source: PM360

Using RBQM and New Technologies to Enhance Data Analysis and Enable Faster Review and Decision Making

An increase in clinical trial data is driving demand for enhanced clinical trial processes. Sponsors want...

Source: Journal for Clinical Studies

Advancing Technology in Clinical Trials

With increasing pressure to overcome drug development challenges and advance drugs to market faster and with...

Source: Contract Pharma

CRO Industry Report

Today’s drug development landscape demands contract research organizations (CROs) provide flexible models that leverage the latest...

Source: Contract Pharma

DIA 2024: Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM

In an interview with ACT editor Andy Studna at DIA 2024, Hughes, co-founder and chief commercial...

Source: Applied Clinical Trials

Does Risk-Based Quality Management (RBQM) Actually Improve Quality?

Over the past 10 years we have seen a lot of progress in risk-based quality management...

Source: ACRP

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 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