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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’ Technology Named as Finalist in 2025 Citeline Awards

RBQM and AI leader was shortlisted for its Time Similarity Test in the ‘Innovative Clinical Trial...

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...

CluePoints named as Finalist in 2025 ACDM Awards

The Company, along with its Research and Development Teams, were shortlisted for continuing its mission of...

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...

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