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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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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

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...

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

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...

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...

CluePoints Appoints Steve Young As Senior Vice President Of US Operations

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions...

CluePoints CEO, François Torche, Honored In PharmaVOICE 100

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has...

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,...

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

SCOPE 2024: Steve Young of CluePoints Discusses RBQM and Key Risk Indicators

In an interview with ACT editor Andy Studna at SCOPE, Young, Chief Science Officer, CluePoints discusses...

Source: Applied Clinical Trials

Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials

Central monitoring aims at improving the quality of clinical research by pro-actively identifying risks and remediating...

Source: Springer Link

Trendspotting: What’s Coming for Clinical Trials and Research in 2024

We spoke with leaders and experts in the Clinical Research community about their predictions for 2024.

...

Source: Clinical Research News

Ukraine War’s Impact on Clinical Research: Evidence from Key Risk Indicators

Key risk indicators (KRIs) are commonly used as an important component of central monitoring to enable...

Source: Applied Clinical Trials

Using Machine Learning and NLP to Improve Central Monitoring Documentation

Central monitoring helps sponsors to proactively identify and remediate data quality issues during the conduct of...

Source: Applied Clinical Trials

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