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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.

AI, Data and Partnerships: The Building Blocks for More Sustainable Clinical Trials
Sas Maheswaran discusses how artificial intelligence, data and strategic partnerships can make clinical...
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5 minutes with… Andrew Cooper, CEO, CluePoints
Andrew Cooper, CEO, CluePoints, explores how AI is transforming clinical trials, the power of a purpose-driven...
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CluePoints’ Technology Named as Finalist in 2025 Citeline Awards
RBQM and AI leader was shortlisted for its Time Similarity Test in the ‘Innovative Clinical Trial Solutions’...
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Benchmarking Risks Across Therapeutic Areas
The monitoring of key risk indicators (KRIs) is an established form of risk control in the conduct of...
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CluePoints Appoints Usama Dar as Chief Product and Technology Officer
King of Prussia, PA – April 1st, 2025: CluePoints, provider of leading statistical and AI-driven software...
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Where is RBQM Heading in The Future With AI?
Richard Young, Chief Strategy Officer at CluePoints, shares insights on AI and risk-based quality management...
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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

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...

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

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

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...

CluePoints Chief Scientific Officer And Pfizer’s Global RBM Program Lead To Speak At #CQOF2021

Join us at #CQOF2021! As well as hosting a booth at the Clinical Quality Oversight Forum...

Will ICH E6 (R3) Unleash The Potential Of Risk-Based Trials?

Researchers have been slow to fully adopt innovations designed to overcome the challenges to modern day...

CluePoints Partners With ZS To Provide Best-In-Class RBQM Expertise And Technology, Increasing Clinical Trial Efficiency And Improving Patient Outcomes

CluePoints, the premier provider of Risk-Based Quality Management software for clinical trials, has partnered with ZS,...

Introducing CluePoints’ Post-COVID Trial Assurance Solution

For well over a year now, the clinical research community has been hard at work to...

Revealing The Bigger Picture Through Metadata & Building RBQM Standards Of The Future

Risk-Based Monitoring is the future of clinical trials – but despite significant advances in recent years,...

CluePoints Sponsors RBQM Live, The Definitive Guide To RBQM For Experts And Beginners

Have you heard the news? CluePoints is sponsoring RBQM Live on behalf of the industry! The...

Centralized Monitoring: Effective Technology & Documented Evidence Are The Perfect Double Act

In the world of clinical trials, if it isn’t documented, it didn’t happen. It’s a philosophy...

CluePoints To Share COVID-Informed RBQM Best Practice At #SCOPE2021

It has never been more important for the clinical trial community to come together and share...

CluePoints’ Risk-Based Quality Management Platform Instrumental In Data Quality Oversight Of COVID-19 Trials

King of Prussia, PA – January 19, 2021: CluePoints, the premier provider of Risk-Based Study Execution...

CluePoints Opens New APAC Office In Tokyo

King of Prussia, PA – December 8th, 2020: CluePoints, the premier provider of Central Statistical Monitoring,...

CluePoints Joins Forces With Global Growth Investor Summit Partners To Expand Market Leadership Position In Risk-Based Quality Management

LOUVAIN-LA-NEUVE, BELGIUM; KING OF PRUSSIA, PA; and LONDON, UK (September 1, 2020) – CluePoints S.A., a...

Over 300 Clinical Studies Benefit From CluePoints’ COVID-19 Risk Management Support

Addressing COVID-19 Specific Regulatory Guidance and Ensuring Early Risk Detection King of Prussia, PA: CluePoints, the...

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

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

Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes

Central monitoring, which typically includes the use of key risk indicators (KRIs), aims at improving the...

Source: Springer Link

Causing a Wave of New Career Opportunities

Clinical research is in the grips of a revolution that has caused a wave of new...

Source: ACRP