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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.

The Unquantified Value of RBQM: Reduced Rework, Data Integrity, and Inspection Readiness
In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD discuss what...
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Why Time Savings Is the Largest Driver of RBQM's Financial Value
In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain why...
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Why Quantifying the Financial Value of RBQM Has Been So Hard- and What This Study Did Differently
In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain how...
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CluePoints Shortlisted for 2026 Scrip Awards Following 2023 and 2025 Wins
The two-time category winner secures finalist position in the Best Contract Research Organization (Specialist...
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Trial Complexity is the New Normal
Clinical trial complexity is now the norm: more endpoints, more procedures, narrower eligibility criteria,...
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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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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

CluePoints Appoints New Chief People Officer to Support Next Phase of Global Growth

King of Prussia, PA – January 12, 2026 – CluePoints, provider of leading statistical and AI-driven...

PharmaVoice’s Crystal Ball: What’s next for AI and drug R&D

As AI finds solid footing in pharma R&D, the technology is slated to yield significant rewards....

Source: PharmaVoice

Trendspotting: Embracing AI, DEI Changes, Restrategizing Research Sites

To kick off 2026, we spoke with industry experts and leaders in the Clinical Research News...

Source: Clinical Research News

CluePoints: how proactive oversight and AI are reshaping clinical trial data management

Dan Beaudry, market owner for risk-based quality management (RBQM) at CluePoints, explains how regulatory shifts and...

Source: Discover Pharma

Eight Reasons Why You Need To Attend CBI’s Global Risk-Based Monitoring Event

This month, experts from across the globe will gather for CBI’s Global Risk-Based Monitoring event, taking...

Explore The ICH E6 Rev2 At Outsourcing In Clinical Trials New England

Arena International’s flagship event, Outsourcing in Clinical Trials New England, is almost upon us. This year’s...

CluePoints Opens U.S. Office

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions...

CluePoints’ Founder To Present On Risk-Based Monitoring At FDA/AdvaMed Conference

The 10th Annual FDA/ADVAMED Medical Devices and Diagnostics Statistical Issues Conference, taking place on April 26,...

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)...

Achieving Optimal Adoption of Risk-Based Quality Management

The need to boost education, shift culture, and embrace new technologies.

...

Source: Applied Clinical Trials

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 good...

Source: International Clinical Trials/European Pharmaceutical Contractors

There’s No Such Thing as Too Much Data

François Torche dispels the myth that, at least in RBQM, there is such a thing as...

Source: PM360

Using RBQM and New Technologies to Enhance Data Analysis and Enable Faster Review and Decision Making

An increase in clinical trial data is driving demand for enhanced clinical trial processes. Sponsors want...

Source: Journal for Clinical Studies

Advancing Technology in Clinical Trials

With increasing pressure to overcome drug development challenges and advance drugs to market faster and with...

Source: Contract Pharma

CRO Industry Report

Today’s drug development landscape demands contract research organizations (CROs) provide flexible models that leverage the latest...

Source: Contract Pharma

DIA 2024: Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM

In an interview with ACT editor Andy Studna at DIA 2024, Hughes, co-founder and chief commercial...

Source: Applied Clinical Trials

Does Risk-Based Quality Management (RBQM) Actually Improve Quality?

Over the past 10 years we have seen a lot of progress in risk-based quality management...

Source: ACRP

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 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