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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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  • 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

  • Press Release
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...

  • 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

  • Press Release
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...

  • 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

  • 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...

  • 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...

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Source: Springer Link

  • 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
CluePoints Strengthens Senior Team With Two Key Appointments

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

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
CluePoints Launches Risk-Based Monitoring Starter Pack To Drive Regulatory Compliance

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions...

  • Press Release
CluePoints Responds To Sponsor And CRO Demand With Two New Appointments

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions...

  • Press Release
CluePoints Builds On Late Phase Work In Japan And Launches Risk-Based Monitoring Roadshow In Tokyo

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions...

  • Press Release
25% Discount Code For Partnerships In Clinical Trials 2017

We’re delighted to announce that we’ll be at Partnerships in Clinical Trials next month! You can...

  • Press Release
CluePoints V1.12.0 Is Live!

Today, we’re excited to announce that we’ve added an abundance of new features to the CluePoints...

  • Press Release
Eight Reasons Why You Need To Attend CBI’s Global Risk-Based Monitoring Event

This month, experts from across the globe will gather for CBI’s Global Risk-Based Monitoring event, taking...

  • Featured Article
Causing a Wave of New Career Opportunities

Clinical research is in the grips of a revolution that has caused a wave of new...

Source: ACRP

  • Featured Article
Achieving Successful Decentralized Trials by Leveraging RBQM and Centralized Monitoring Oversight

Virtual or decentralized clinical trials present a far more patient-centric approach to conducting clinical research, building...

Source: Applied Clinical Trials

  • Featured Article
Risk-Based Quality Management Perfect for DCTS

A leader from the RBQM solutions specialists offers a preview of his SCOPE 2022 presentation on...

Source: Outsourcing Pharma

  • Featured Article
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring

A central statistical assessment of the quality of data collected in clinical trials can improve the...

Source: National Library of Medicine

  • Featured Article
Unlocking the Potential of Risk-Based Quality Monitoring

Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) are shifting the clinical research landscape, dramatically accelerating...

Source: Applied Clinical Trials

  • 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

  • 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

  • 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

  • Featured Article
Using Statistics to Improve Data Quality and Maximize Trial Success

Poor quality data has the potential to destroy the validity of a clinical trial, wasting precious...

Source: Tufts Center for the Study of Drug Development

  • 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

  • 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

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