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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 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...

  • Press Release
Explore The ICH E6 Rev2 At Outsourcing In Clinical Trials New England

Arena International’s flagship event, Outsourcing in Clinical Trials New England, is almost upon us. This year’s...

  • Press Release
CluePoints Opens U.S. Office

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

  • Press Release
CluePoints’ Founder To Present On Risk-Based Monitoring At FDA/AdvaMed Conference

The 10th Annual FDA/ADVAMED Medical Devices and Diagnostics Statistical Issues Conference, taking place on April 26,...

  • Press Release
CluePoints Launches Patient Profiles As Latest Addition To Its Risk-Based Monitoring And Data Quality Oversight Solution

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

  • Press Release
CluePoints COO, Steve Young, To Present On Statistical Probability Analysis At MCC’s Central Monitoring Workgroup

The Central Monitoring Workgroup will feature speakers from several solution providers who will each present and...

  • Press Release
Patient Profiles Unveiled As Latest Addition To CluePoints’ Risk-Based Monitoring And Data Quality Oversight Solution

We’re thrilled to announce that version 1.11.0 of CluePoints’ Central Monitoring platform, the enabling SaaS platform...

  • 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...

  • 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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