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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.

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...
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The Modern CRA: Operationalizing Data-Driven Site Success
As clinical trials become more complex, leading sponsors are shifting the focus of their clinical research...
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KRI Overload: When More Isn’t Better
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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...
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CluePoints Sponsored RBQMLive Returns for 2025
KING OF PRUSSIA, Pa., Sept. 23, 2025 /PRNewswire/ — CluePoints, the premier sponsor of RBQMLive...
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Using AI and Advanced Analytics to Transform Clinical Trials
Ken McFarlane of CluePoints shares insight on better, smarter ways to detect risk, streamline data review,...
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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....

How SMEs Can Achieve Regulatory Compliance Through a Risk-Based Approach

Since the introduction of the ICH E6 (R2) addendum, the industry has seen a rise in...

Source: Pharma Focus Asia

Update on ICH E6 (R2) Guideline for GCP

The ICH E6 R2 Addendum is starting to have a significant, positive impact on clinical trial...

Source: Contract Pharma

A Revolutionary Cure for RBM and Centralized Monitoring

In the clinical trials industry there is a tendency to watch and wait, which has been...

Source: PharmaIQ

Announcing The CluePoints Data Quality Challenge

Are you struggling with how to assess the true value of improving data quality and integrity...

The CluePoints & HighPoint Solutions Risk-Based Monitoring Roadshow Recap

The other week, CluePoints in conjunction with HighPoint Solutions delivered 3 European Roadshows in Basel, Copenhagen...

CluePoints Strengthens Senior Team With Two Key Appointments

Wayne, PA – October 02, 2018: CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data...

Quanticate Partners With CluePoints To Offer Data Quality Oversight Capabilities

Quanticate, a data-focused clinical research organisation (CRO), has announced that it has partnered with CluePoints to...

The CluePoints & HighPoint Solutions RBM Roadshow Is Coming To A City Near You!

Since the initial publication of the ICH GCP guidelines, the way clinical trials operate has changed...

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...

Citeline Finalist CluePoints Show Advanced AI Capabilities

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

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...

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...

CluePoints Appoints Andy Cooper as New Chief Executive Officer

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

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...

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...

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...

CluePoints Continues Impressive Global Growth with Three New Senior Appointments

King of Prussia, PA – April 5, 2022: CluePoints, the premier provider of Risk-Based Study Execution...

UK Regulator Cites CluePoints’ Solutions in Updated Guidance

King of Prussia, PA – 7th March 2022: CluePoints, the premier provider of Risk-Based Study Execution...

CluePoints Senior Vice President, Europe, and APAC, to Speak at SCOPE 2022

John Hall, Senior Vice President, EU, and APAC, at CluePoints, will share insights into delivering successful...

HiRO and CluePoints Partnership Offers Market-Leading RBQM Opportunities in China

King of Prussia, PA: Harvest Integrated Research Organization (HiRO), a Shanghai-based Clinical Research Organization (CRO), has...

CluePoints Wins Scrip Award for Clinical Advance of the Year 2021

CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical...

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

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