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Scope of Industry Risk-Based Quality Management (RBQM) Adoption Revealed
King of Prussia, PA: A comprehensive assessment of risk-based quality management (RBQM) adoption has...
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CluePoints on overcoming scepticism and the benefits of AI to optimize trial strategies
Patrick Hughes, co-founder and chief commercial officer of Cluepoints and OSP caught up for an in-person...
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CluePoints’ Audit Trail Review Project Wins Award for Innovation in the Management of Clinical Data Award
King of Prussia, PA – March 5, 2024: CluePoints, providers of best-in-class statistical and AI-driven...
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Centralized Monitoring in Clinical Trials: Everything You Should Know
What Is Centralized Monitoring? Centralized monitoring is a component of risk-based quality management...
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SCOPE 2024: Steve Young of CluePoints Discusses RBQM and Key Risk Indicators
In an interview with ACT editor Andy Studna at SCOPE, Young, Chief Science Officer, CluePoints discusses...
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Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
Central monitoring aims at improving the quality of clinical research by pro-actively identifying risks...
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  • 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

  • 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

  • Press Release
Study shows KRIs improve data quality when used as part of a holistic RBQM plan

Authors: Steve Young, Chief Scientific Officer Sylviane de Viron, Data and Knowledge Manager In the face...

  • Press Release
RBQM Market Leader, CluePoints, Celebrates Milestone of De-risking 1000 Clinical Studies

King of Prussia, PA – 6 February 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • 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...

  • 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

  • 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!...

  • Press Release
CluePoints Founder, Marc Buyse To Deliver Clinical Trial Data Quality Course At The ASA Biopharmaceutical Workshop

The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is fast approaching and we’re thrilled to announce that...

  • Press Release
Unveiling CluePoints’ New And Improved Risk-Based Monitoring Software

Today, we’re thrilled to unveil CluePoints’ latest release of its award-winning Risk-Based Monitoring Software. For this...

  • Press Release
CluePoints Announce 2nd Annual Risk-Based Monitoring Roadshows To Take Place In Basel, Switzerland & Cambridge, UK

Join CluePoints CEO Francois Torche and OmniComm Sr. Director Steve Young at this special thought leadership...

  • Press Release
CluePoints Named Clinical Research & Excellence Awards Finalist

Awards recognize CluePoints’ Risk-Based Monitoring solution in the ‘Best Sponsor-Focused Technological Development’ category. Cambridge, MA –...

  • 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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