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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: An Updated View of Industry Trends
We presented an initial review of quality tolerance limit (QTL) adoption trends in the March 2023 issue...
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FDA and CluePoints extend collaboration to enhance clinical trial integrity and safety
Yesterday (June 5) CluePoints, providers of established statistical and AI-driven software solutions,...
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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...
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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...
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The Risk-Based Data Management (RBDM) Revolution
The clinical trials landscape is evolving with more data, increased investment in personalized medicines...
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Leveraging Machine Learning and Deep Learning for Natural Language Processing in Clinical Data Management
Nicolas Huet, CluePoints Machine Learning Manager, discusses developments in the use of machine learning...
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  • Press Release
Over 300 Clinical Studies Benefit From CluePoints’ COVID-19 Risk Management Support

Addressing COVID-19 Specific Regulatory Guidance and Ensuring Early Risk Detection King of Prussia, PA: CluePoints, the...

  • Press Release
CluePoints & DIA Webinar: How Is The Industry Coping With The Move To Remote Monitoring?

On July 28, CluePoints is teaming up with DIA for a webinar to explore how the...

  • Press Release
CluePoints Launches Powerful Business Intelligence Platform

Personalizing the Power of Statistical Analysis and Data Visualization King of Prussia, PA: CluePoints, the premier...

  • Press Release
CluePoints Covid-19 Support Benefits Over 200 Clinical Studies Directly Affected By The Pandemic

RISK MANAGEMENT SOLUTION ADDRESSES FDA, EMA, PMDA & MHRA CORONAVIRUS ADVICE King of Prussia, PA: CluePoints,...

  • Featured Article
Why Risk-Based Quality Management Represents the Future of Clinical Research

By empowering researchers to detect data quality issues in real-time, Risk-Based Quality Management (RBQM) and Risk-Based...

Source: Journal for Clinical Studies

  • Press Release
EPS Corporation Signs Groundbreaking Agreement To Drive Increased Quality And Safety Using CluePoints RBQM Solution

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

  • Press Release
CluePoints Launches Complimentary COVID-19 Risk Management Package For Clinical Studies

Risk Planning Guidance Addresses FDA, EMA, PMDA and MHRA Coronavirus Advice King of Prussia, PA: CluePoints,...

  • Featured Article
Managing Clinical Trials Amid the Coronavirus Pandemic

Amid the ongoing Coronavirus pandemic, clinical trial sites are increasingly inaccessible for patients and site staff,...

Source: Tufts Center for the Study of Drug Development

  • Press Release
Webinar Recording: The Critical Importance Of Early Risk Detection With A Special Feature Addressing COVID-19

We’re delighted to announce that the recording for our COVID-19 webinar has been posted! About the...

  • Press Release
CluePoints’ Central Statistical Monitoring Supports Business Continuity As Coronavirus Impacts Clinical Trial Operations

Remote monitoring is mitigating the impact of SARS-CoV-2 on clinical trials, marking an acceleration in the...

  • Featured Article
Effective Risk Management When Using eCOA and ePRO

The use of direct source data capture in clinical research is on the rise, both during...

Source: Clinical Research News

  • Featured Article
Leveraging Audit Trails to Monitor Clinical Study Risk

The clinical research industry has gone through an important transformation over the past 15 to 20...

Source: ACRP

  • Press Release
Revealing The Bigger Picture Through Metadata & Building RBQM Standards Of The Future

Risk-Based Monitoring is the future of clinical trials – but despite significant advances in recent years,...

  • Press Release
CluePoints Sponsors RBQM Live, The Definitive Guide To RBQM For Experts And Beginners

Have you heard the news? CluePoints is sponsoring RBQM Live on behalf of the industry! The...

  • Press Release
Centralized Monitoring: Effective Technology & Documented Evidence Are The Perfect Double Act

In the world of clinical trials, if it isn’t documented, it didn’t happen. It’s a philosophy...

  • Press Release
CluePoints To Share COVID-Informed RBQM Best Practice At #SCOPE2021

It has never been more important for the clinical trial community to come together and share...

  • Press Release
CluePoints’ Risk-Based Quality Management Platform Instrumental In Data Quality Oversight Of COVID-19 Trials

King of Prussia, PA – January 19, 2021: CluePoints, the premier provider of Risk-Based Study Execution...

  • Press Release
CluePoints Opens New APAC Office In Tokyo

King of Prussia, PA – December 8th, 2020: CluePoints, the premier provider of Central Statistical Monitoring,...

  • Press Release
CluePoints Joins Forces With Global Growth Investor Summit Partners To Expand Market Leadership Position In Risk-Based Quality Management

LOUVAIN-LA-NEUVE, BELGIUM; KING OF PRUSSIA, PA; and LONDON, UK (September 1, 2020) – CluePoints S.A., a...

  • Press Release
Over 300 Clinical Studies Benefit From CluePoints’ COVID-19 Risk Management Support

Addressing COVID-19 Specific Regulatory Guidance and Ensuring Early Risk Detection King of Prussia, PA: CluePoints, the...

  • Press Release
CluePoints & DIA Webinar: How Is The Industry Coping With The Move To Remote Monitoring?

On July 28, CluePoints is teaming up with DIA for a webinar to explore how the...

  • Press Release
CluePoints Launches Powerful Business Intelligence Platform

Personalizing the Power of Statistical Analysis and Data Visualization King of Prussia, PA: CluePoints, the premier...

  • Press Release
CluePoints Covid-19 Support Benefits Over 200 Clinical Studies Directly Affected By The Pandemic

RISK MANAGEMENT SOLUTION ADDRESSES FDA, EMA, PMDA & MHRA CORONAVIRUS ADVICE King of Prussia, PA: CluePoints,...

  • Press Release
EPS Corporation Signs Groundbreaking Agreement To Drive Increased Quality And Safety Using CluePoints RBQM Solution

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

  • 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

  • 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

  • Featured Article
RBQM: A Natural Evolution to Achieve Gold Standard Clinical Trial Management (Pages 38-39)

The success of clinical development programmes, drug approval and marketing depends ultimately on the readability and...

Source: International Clinical Trials

  • Featured Article
Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes

Central monitoring, which typically includes the use of key risk indicators (KRIs), aims at improving the...

Source: Springer Link

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