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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.

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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The Negative Impact of Failing to Implement Risk-Based Quality Management
As an industry, we regularly discuss the benefits of adopting risk-based quality management (RBQM). The...
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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

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

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

Clinical Research 2.0 Must Embrace Change

We are at a tipping point in the adoption of Clinical Research 2.0. The evolution of...

Source: PM360

Women in Science: Dr Laura Trotta – ‘I joined CluePoints because of the research but also the mindset’

Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as vice president...

Source: OutsourcingPharma

CluePoints’ Site Profile & Oversight Tool (SPOT) shortlisted as finalist in 2024 Citeline Awards

King of Prussia, PA – March 25, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

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 revealed that...

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...

Source: OutsourcingPharma

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 software...

Centralized Monitoring in Clinical Trials: Everything You Should Know

What Is Centralized Monitoring? Centralized monitoring is a component of risk-based quality management (RBQM) that aims...

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...

Source: Applied Clinical Trials

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 and remediating...

Source: Springer Link

CluePoints Appoints Richard Young as Chief Strategy Officer

CluePoints Appoints Richard Young as Chief Strategy Officer King of Prussia, PA – October 28th, 2024:...

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...

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 with this latest...

CluePoints Continues ‘Turning Artificial Intelligence into Human Intelligence’ by Launching Two New Innovations

Site Profile & Oversight Tool (SPOT) and Intelligent Medical Coding (IMC) unveiled by RBQM innovator at...

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 oversight in...

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, today unveiled...

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 Food and...

CluePoints’ Site Profile & Oversight Tool (SPOT) shortlisted as finalist in 2024 Citeline Awards

King of Prussia, PA – March 25, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

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 revealed that...

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 software...

Centralized Monitoring in Clinical Trials: Everything You Should Know

What Is Centralized Monitoring? Centralized monitoring is a component of risk-based quality management (RBQM) that aims...

Game-Changing ‘Audit Trail Review’ Application Secures ACDM 2024 Awards Nomination for CluePoints

King of Prussia, PA – February 6, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

CluePoints announces full agenda and speakers for free RBQM event next month

Risk-based quality management (RBQM) is used to identify and assess risks then finding ways to manage...

Source: OutsourcingPharma

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

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

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

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

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

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

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...

Source: Springer Link

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

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

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

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