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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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Does Risk-Based Quality Management (RBQM) Actually Improve Quality?
Over the past 10 years we have seen a lot of progress in risk-based quality management (RBQM) adoption...
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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...
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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,...
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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 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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  • Press Release
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...

  • 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...

  • 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...

  • 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

  • Press Release
CluePoints’ Risk-Based Monitoring Solution Receives Clinical Informatics News Best Practices Award

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring solutions for clinical trials, today announced...

  • Press Release
CluePoints – Finalists In The Clinical Informatics News 2017 Best Practices Awards At SCOPE, Jan 24th – 26th In Miami

We’re thrilled to announce that CluePoints has been named as finalists for the Clinical Informatics News...

  • Press Release
CluePoints CEO, Francois Torche, To Present At SCOPE Summit For Clinical Ops Executives

The 8th Annual SCOPE Summit for Clinical Ops Executives, taking place on January 24-26, 2017 in...

  • Press Release
CluePoints Partners With Metrics Champion Consortium To Define Metrics And Standards For Centralized Monitoring

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) and Risk-Based Monitoring(RBM) solutions...

  • Press Release
CluePoints Introduces Data Quality Oversight Service For Site Inspection Readiness

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Centralized Statistical Monitoring (CSM)...

  • Press Release
FDA Signs Agreement With CluePoints To Explore A Data-Driven Approach To Quality Oversight In Clinical Trials

Cambridge, MA – FDA and its stakeholders have an interest in assuring the integrity of clinical...

  • Press Release
CluePoints Teams Up With Paragon Solutions To Share The Secrets Of Successful Risk-Based Monitoring Implementation

We’re delighted to announce that are our next Risk-Based Monitoring implementation webinar is open for registration!...

  • Press Release
CluePoints Announces Locations For Risk-Based Monitoring Implementation Roadshows

The CluePoints and OmniComm Risk-Based Monitoring Implementation Roadshow is Coming to a City Near You! In...

  • Press Release
CluePoints Announces Free Risk-Based Monitoring Strategy Review

We’re thrilled to announce that CluePoints is now offering a complimentary Risk-Based Monitoring strategy Check-up and...

  • Press Release
CluePoints Appoints Steve Young As Senior Vice President Of US Operations

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

  • Press Release
CluePoints CEO, François Torche, Honored In PharmaVOICE 100

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has...

  • Press Release
CluePoints Risk-Based Monitoring Platform (Version 1.9.0) Is Live!

We’re thrilled to announce that CluePoints’ latest version (1.9.0) of the Central Monitoring platform is live!...

  • 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

  • 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

  • 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

  • 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

  • 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

  • Featured Article
Update on ICH E6 (R2) Guideline for GCP

The ICH E6 R2 Addendum is starting to have a significant, positive impact on clinical trial...

Source: Contract Pharma

  • Featured Article
A Revolutionary Cure for RBM and Centralized Monitoring

In the clinical trials industry there is a tendency to watch and wait, which has been...

Source: PharmaIQ

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