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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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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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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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  • 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.

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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...

  • Featured Article
FDA Offers Further RBM Guidance Stressing Data Quality Oversight

Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a...

Source: Outsourcing Pharma

  • Press Release
New! Registration Open For CluePoints’ RBM Roadshows – Pick From San Francisco Or La Jolla!

We’re delighted to announce that registration for CluePoints’ US Risk-Based Quality Management Roadshow is now open....

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
CluePoints Supports Launch of RBQM Live 2023 as Premier Event Sponsor

King of Prussia, PA – May 3, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • Press Release
CluePoints Announces Amit Patel as New CFO

King of Prussia, PA: RBQM leader, CluePoints, has today announced that Amit Patel will join as...

  • Press Release
Citeline Finalist CluePoints Show Advanced AI Capabilities

King of Prussia, PA – March 23rd, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • Press Release
Study shows KRIs improve data quality when used as part of a holistic RBQM plan

Authors: Steve Young, Chief Scientific Officer Sylviane de Viron, Data and Knowledge Manager In the face...

  • Press Release
RBQM Market Leader, CluePoints, Celebrates Milestone of De-risking 1000 Clinical Studies

King of Prussia, PA – 6 February 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • Press Release
CluePoints Appoints Andy Cooper as New Chief Executive Officer

King of Prussia, PA – December 13, 2022: RBQM leader, CluePoints, has today announced Andy Cooper...

  • Press Release
RBQM market leader, CluePoints, marks its tenth anniversary as ICH E6 (R3) looks set to mandate the company’s data-driven approach across all clinical trials

King of Prussia, PA – October 12th, 2022: Risk-based quality management (RBQM) solutions provider, CluePoints, is...

  • Press Release
Federated Learning & Risk-Based Data Management – The Future of Smart Healthcare

According to CluePoints Senior Vice President John Hall, “Federated learning is a critical evolution in the...

  • Press Release
CluePoints Wins Citeline Award for Excellence in Innovation in Response to COVID-19 – Clinical Trial Activities

King of Prussia, PA – April 11, 2022: CluePoints, the premier provider of Risk-Based Study Execution...

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
Achieving Optimal Adoption of Risk-Based Quality Management

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

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Source: Applied Clinical Trials

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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