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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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Central Monitoring Use in Early-Phase and Small Enrollment Trials
Central monitoring is highly effective in detecting emerging quality issues in clinical trials, but debate...
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Risk Planning: A Review of Industry Trends
An essential component of risk-based quality management (RBQM), as detailed in both the ICH E8 (R1) and...
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CluePoints Appoints Richard Young as Chief Strategy Officer
CluePoints Appoints Richard Young as Chief Strategy Officer King of Prussia, PA – October 28th, 2024:...
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CluePoints Wins Growth Award at BVA Private Equity Awards
King of Prussia, PA – October 23rd, 2024: CluePoints, provider of leading statistical and AI-driven software...
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Achieving Optimal Adoption of Risk-Based Quality Management
The need to boost education, shift culture, and embrace new technologies.
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CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review
CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency...
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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 & 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...

  • 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,...

  • 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...

  • Press Release
CluePoints’ Risk-Based Quality Management (RBQM) Software Wins At Scrip Awards 2019

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

  • 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...

  • 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...

  • 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...

  • 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
DIA 2024: Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM

In an interview with ACT editor Andy Studna at DIA 2024, Hughes, co-founder and chief commercial...

Source: Applied Clinical Trials

  • Featured Article
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...

Source: ACRP

  • Featured Article
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...

Source: Applied Clinical Trials

  • Featured Article
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, and the Food and...

Source: Outsourcing Pharma

  • Featured Article
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...

Source: Applied Clinical Trials

  • Featured Article
The Risk-Based Data Management (RBDM) Revolution

The clinical trials landscape is evolving with more data, increased investment in personalized medicines and a...

Source: Clinical Research News

  • Featured Article
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 and deep...

Source: Pharmaceutical Outsourcing

  • Featured Article
The Future of RBQM Adoption

In the fifth and final part of this video interview series, Ken Getz, executive director and...

Source: Applied Clinical Trials

  • Featured Article
Potential Pitfalls Without RBQM Adoption

In part 4 of this video interview series, Ken Getz, executive director and research professor, Tufts...

Source: Applied Clinical Trials

  • Featured Article
Increasing Comfortability With Adopting Risk-Based Approaches

In part 3 of this video interview series, Ken Getz, executive director and research professor, Tufts...

Source: Applied Clinical Trials

  • Featured Article
Ken Getz of Tufts CSDD and Steve Young of CluePoints Discuss Stand Out Results from Recent RBQM Study

In part 2 of this video interview series, Ken Getz, executive director and research professor, Tufts...

Source: Applied Clinical Trials

  • Featured Article
Ken Getz of Tufts CSDD Discusses RBQM Study Conducted with CluePoints and PwC

In part 1 of this video interview series with Ken Getz, executive director and research professor,...

Source: Applied Clinical Trials

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