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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...
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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 too much data, and...
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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...
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Vox Pop Pharma – where will AI take the industry in the next five years?
Artificial intelligence (AI) is a hot topic in pharma with myriad uses such as supporting clinical research...
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Advancing Technology in Clinical Trials
With increasing pressure to overcome drug development challenges and advance drugs to market faster and...
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CRO Industry Report
Today’s drug development landscape demands contract research organizations (CROs) provide flexible models...
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  • 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 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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
CluePoints Chief Scientific Officer to Speak at CNS Summit Next Month

Steve Young, Chief Scientific Officer at CluePoints, will take to the podium at this year’s CNS...

  • Press Release
CluePoints SVP of Business Development to Speak at Clinical Trials Europe

John Hall, SVP Business Development at CluePoints will share insights into the dimensions of risk associated...

  • Press Release
CluePoints Shortlisted for Multiple Awards in Recognition of Pioneering Risk-Based Quality Management Solution

King of Prussia, PA: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality...

  • Featured Article
DIA 2023 Topic: The Industry-Wide Definition for RBQM

At the recent DIA 2023 Global Annual Conference, I focused my attention on discussions about the...

Source: Clinical Research News

  • 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
CluePoints announces full agenda and speakers for free RBQM event next month

Risk-based quality management (RBQM) is used to identify and assess risks then finding ways to manage...

Source: OutsourcingPharma

  • 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
Paving the path for risk-based quality management and sharing insight at DIA Global

CluePoints is continuing to invest in artificial intelligence (AI) and machine learning (ML) they say they...

Source: Outsourcing Pharma

  • Featured Article
Interview: How CluePoints is making clinical trials ‘safer, streamlined and more efficient’

With the clinical trial landscape continuing to evolve and adapt, OSP took the opportunity to speak...

Source: Outsourcing Pharma

  • 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

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