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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.

Six geese a-laying: CluePoints’ AI predictions for 2026
Returning to the series is CluePoints, with Sophie Henderson, senior strategic consultant, sharing her...
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Predictions for the Future of Risk-Based Quality Management (RBQM)
Regulatory changes, including the launch of ICH E6(R3) and Good Clinical Practice (GCP) updates, have...
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Today Discover Pharma launches its annual 12 Days of Christmas campaign featuring CluePoints insight on RBQM
Sophie Henderson, Senior Strategic Consultant at CluePoints, said: “This year we have seen risk-based...
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CluePoints Scoops Prestigious 2025 Scrip Award
CluePoints Scoops Prestigious 2025 Scrip Award RBQM and AI leader wins the ‘Best Contract Research Organization...
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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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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...

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

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...

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

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...

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

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...

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

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...

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

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

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...

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.

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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