News

Latest Industry Updates

From company milestones to industry breakthroughs, uncover the stories making waves and shaping the narrative in real time.

Featured Article Category Icon
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)...
Read
Featured Article Category Icon
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...
Read
Press Release Category Icon
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...
Read
Featured Article Category Icon
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...
Read
Featured Article Category Icon
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...
Read
Featured Article Category Icon
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...
Read
1 2 3 … 32
  • 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.

...

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....

  • Featured Article
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

  • 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...

  • Press Release
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...

  • Press Release
UK Regulator Cites CluePoints’ Solutions in Updated Guidance

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

  • Press Release
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...

  • Featured Article
Statistics Powering Risk-Based Quality Management

CluePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical...

Source: DIA

  • Featured Article
RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)

A conversation with Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts...

Source: Clinical Leader

  • Featured Article
Women in Pharma 2023 | Growing Leadership and Choosing Your Priorities

The pharmaceutical industry has a problem – a failure to provide women with C-suite opportunities.

...

Source: International Clinical Trials

  • Featured Article
ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?

The ICH E6(R3) draft guideline document, currently open to public consultation, places the industry firmly in...

Source: Applied Clinical Trials

  • Featured Article
RBQM Elements Have Seen Limited Adoption in Trials, New Global Survey Finds

Despite the push for greater use of risk-based quality management (RBQM) in clinical research, adoption of...

Source: CenterWatch

  • Featured Article
Industry Trends: Cycle Time to Resolve Risk Signals

Central monitoring aims to detect emerging quality-related risks proactively during a clinical trial, resulting in study...

Source: Applied Clinical Trials

  • Featured Article
The Role of KRIs in Process-Driven RBQM Success

Using key risk indicators (KRIs) can improve clinical trial data quality in 80% of the sites...

Source: Applied Clinical Trials

  • Featured Article
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters

Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and...

  • Read

Source: Springer Link

  • Featured Article
Quality Tolerance Limits: A Review of Industry Trends

An expectation for the use of quality tolerance limits (QTLs) was formally established in the International...

Source: Applied Clinical Trials

  • Featured Article
The Role of Transferable Skills and Data Science in the Move to Digitally-Enabled Clinical Research

Clinical research is evolving rapidly, with the digitalization of trials creating a new modus operandi and...

Source: Applied Clinical Trials

  • Featured Article
The Eradication of False Signals in Monitoring

Risk-based approaches to monitoring clinical trials were brought to the forefront with an FDA guidance published...

Source: Applied Clinical Trials

  • Featured Article
Identifying Important Risk Indicators in Clinical Development

Key risk indicators (KRIs) are metrics designed to identify risks of specific interest to study teams...

Source: Applied Clinical Trials

CluePoints RBQM Live25 On-Demand Recordings are now Available! Banner - ROI of RBQM, ICH E6(R3) in Practice, Future of AI