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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.

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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Trendspotting: Embracing AI, DEI Changes, Restrategizing Research Sites
To kick off 2026, we spoke with industry experts and leaders in the Clinical Research News community...
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CluePoints: how proactive oversight and AI are reshaping clinical trial data management
Dan Beaudry, market owner for risk-based quality management (RBQM) at CluePoints, explains how regulatory...
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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...

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

CluePoints Awarded Most Reputable Clinical Trial Risk-Based Monitoring Software 2018

It appears that 2018 is the year CluePoints really established itself as a leader in the...

CluePoints Announces Four Year Partnership With ONO Pharmaceutical And Strengthens Risk-Based Monitoring Position In Japan

Successful pilot project prompts strategic partnership that strengthens risk-based monitoring in Japan and places both companies...

CluePoints Wins Best Risk-Based Monitoring Solution In 2018 Biotechnology Awards

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

CluePoints Launches Risk-Based Monitoring Starter Pack To Drive Regulatory Compliance

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

CluePoints Responds To Sponsor And CRO Demand With Two New Appointments

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

CluePoints Builds On Late Phase Work In Japan And Launches Risk-Based Monitoring Roadshow In Tokyo

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

25% Discount Code For Partnerships In Clinical Trials 2017

We’re delighted to announce that we’ll be at Partnerships in Clinical Trials next month! You can...

CluePoints V1.12.0 Is Live!

Today, we’re excited to announce that we’ve added an abundance of new features to the CluePoints...

Eight Reasons Why You Need To Attend CBI’s Global Risk-Based Monitoring Event

This month, experts from across the globe will gather for CBI’s Global Risk-Based Monitoring event, taking...

Explore The ICH E6 Rev2 At Outsourcing In Clinical Trials New England

Arena International’s flagship event, Outsourcing in Clinical Trials New England, is almost upon us. This year’s...

CluePoints Opens U.S. Office

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

CluePoints’ Founder To Present On Risk-Based Monitoring At FDA/AdvaMed Conference

The 10th Annual FDA/ADVAMED Medical Devices and Diagnostics Statistical Issues Conference, taking place on April 26,...

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

The Future of AI in pharma: Beyond the buzz to real-world impact

Artificial Intelligence (AI) continues to gain momentum in the pharmaceutical sector, but can it truly deliver...

Source: Health Tech World

Around the Health Tech World: Dr Laura Trotta, CluePoints

Dr Laura Trotta gives us an insight into her role at CluePoints and shares some of...

Source: Health Tech World

AI, Data and Partnerships: The Building Blocks for More Sustainable Clinical Trials

Sas Maheswaran discusses how artificial intelligence, data and strategic partnerships can make clinical trials more sustainable...

Source: ONdrugDelivery

5 minutes with… Andrew Cooper, CEO, CluePoints

Andrew Cooper, CEO, CluePoints, explores how AI is transforming clinical trials, the power of a purpose-driven...

Source: European Medical Journal GOLD

Benchmarking Risks Across Therapeutic Areas

The monitoring of key risk indicators (KRIs) is an established form of risk control in the...

Source: Applied Clinical Trials

Where is RBQM Heading in The Future With AI?

Richard Young, Chief Strategy Officer at CluePoints, shares insights on AI and risk-based quality management (RBQM)...

Source: The Clinical Trial Vanguard

Think Tank 2025 Pharma Forecast: What Lies Ahead for the Industry in 2025?

The pharmaceutical industry is poised for a transformative evolution by 2025, driven by the possibilities of...

Source: PM360

Central Monitoring Use in Early-Phase and Small Enrollment Trials

Central monitoring is highly effective in detecting emerging quality issues in clinical trials, but debate continues...

Source: Applied Clinical Trials

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