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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.

CluePoints Launches Three AI-Led Clinical Data Review Capabilities, Co-Innovated with a Top 10 Pharmaceutical Company
Intelligent Query Detection, Medical & Safety Review and Intelligent Medical Coding are now generally...
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Making the Financial Case for Risk-Based Quality Management in Clinical Research- Q&A
New peer-reviewed research puts hard numbers to the financial value of RBQM, showing ROI multiples up...
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The CRA of the Future
Clinical research associates are evolving from compliance-focused manual monitors to data-enabled strategic...
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Applying Risk-Based Oversight to Ensure Real-World Data Integrity
Clinical trials have undergone a period of immense change. Use of real-world data (RWD) is increasing....
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CluePoints Appoints Martin Magazzolo as Chief Commercial Officer
Wayne, PA – July 27, 2026 – CluePoints, provider of leading statistical and AI-driven software solutions,...
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How RBQM Fits Into An AI World
How risk-based quality management (RBQM) can harness the power of AI and advanced analytics to transform...
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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

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...

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...

CluePoints Appoints Andy Cooper as New Chief Executive Officer

King of Prussia, PA – December 13, 2022: RBQM leader, CluePoints, has today announced Andy Cooper...

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

RBQM market leader, CluePoints, marks its tenth anniversary as ICH E6 (R3) looks set to mandate the company’s data-driven approach across all clinical trials

King of Prussia, PA – October 12th, 2022: Risk-based quality management (RBQM) solutions provider, CluePoints, is...

Federated Learning & Risk-Based Data Management – The Future of Smart Healthcare

According to CluePoints Senior Vice President John Hall, “Federated learning is a critical evolution in the...

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

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...

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 wins SCRIP Awards for Best Contract Research Organization (CRO): Specialist Providers

King of Prussia, PA – October 17, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

Pioneering AI solutions and a commitment to industry-wide RBQM advancement secures CluePoints a finalist position in the 2023 SCRIP Awards

King of Prussia, PA – October 12, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

Making the Financial Case for Risk-Based Quality Management in Clinical Research- Q&A

New peer-reviewed research puts hard numbers to the financial value of RBQM, showing ROI multiples up...

Source: The Association of Clinical Research Professionals

The CRA of the Future

Clinical research associates are evolving from compliance-focused manual monitors to data-enabled strategic site partners, but organizations...

Source: Applied Clinical Trials

Applying Risk-Based Oversight to Ensure Real-World Data Integrity

Clinical trials have undergone a period of immense change. Use of real-world data (RWD) is increasing....

Source: PharmaLive

How RBQM Fits Into An AI World

How risk-based quality management (RBQM) can harness the power of AI and advanced analytics to transform...

Source: Journal for Clinical Studies

How agentic AI is shifting data management from time-consuming investigation to confident confirmation

AI is reshaping clinical data management (DM), moving the industry away from time-consuming, inefficient processes and...

Source: PharmaTimes Magazine

How AI and Advanced Statistics Are Helping Research Rise

Clinical trials are undergoing a period of change. Innovative uses of artificial intelligence (AI) are unlocking...

Source: Applied Clinical Trials

Safety Reporting in RBQM: Bridging Risk Assessment, Monitoring, and Action

Safety reporting is a critical aspect of clinical trial quality, directly impacting patient safety and regulatory...

Source: Applied Clinical Trials

Is Agentic AI The ‘Next Leap Forward’ for Clinical Trial Data Management?

In clinical trials, every second counts, both for patient outcomes and sponsor ROI. As data volumes...

Source: Clinical Research News

When Women Thrive, We all Rise

The theme for this year’s International Women’s Day (IWD) on 8th March was ‘Give to Gain’....

Source: Pharmaphorum

Quality Tolerance Limits: Why Breaches Happen Early and How to Act Fast

Quality tolerance limits (QTLs) are trial-level thresholds on critical-to-quality (CtQ) factors—key measures where sustained deviation could...

Source: Applied Clinical Trials

Transitioning to risk-based clinical trial management under ICH E6(R3)

Risk-based quality management (RBQM) is becoming central to clinical trial oversight, with ICH E6(R3) emphasising proportional,...

Source: Discover Pharma

A Signal Isn’t Resolved Until It Stays Closed—RBQM Lessons

Analysis of more than 880 clinical trials shows that while statistical data monitoring and key risk...

Source: Applied Clinical Trials