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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.

Six geese a-laying: CluePoints’ AI predictions for 2026
Returning to the series is CluePoints, with Sophie Henderson, senior strategic consultant, sharing her...
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Predictions for the Future of Risk-Based Quality Management (RBQM)
Regulatory changes, including the launch of ICH E6(R3) and Good Clinical Practice (GCP) updates, have...
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Today Discover Pharma launches its annual 12 Days of Christmas campaign featuring CluePoints insight on RBQM
Sophie Henderson, Senior Strategic Consultant at CluePoints, said: “This year we have seen risk-based...
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CluePoints Scoops Prestigious 2025 Scrip Award
CluePoints Scoops Prestigious 2025 Scrip Award RBQM and AI leader wins the ‘Best Contract Research Organization...
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CluePoints Data and Knowledge Manager Appointed to ACT Editorial Advisory Board
King of Prussia, PA – November 5th, 2025: CluePoints, provider of leading statistical and AI-driven software...
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The Modern CRA: Operationalizing Data-Driven Site Success
As clinical trials become more complex, leading sponsors are shifting the focus of their clinical research...
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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

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

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

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

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...

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 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...

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...

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...

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...

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...

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...

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...

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)...

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...

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!...

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...

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...

Statistics Powering Risk-Based Quality Management

CluePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical...

Source: DIA

RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)

A conversation with Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts...

Source: Clinical Leader

Women in Pharma 2023 | Growing Leadership and Choosing Your Priorities

The pharmaceutical industry has a problem – a failure to provide women with C-suite opportunities.

...

Source: International Clinical Trials

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

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