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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.

When Women Thrive, We all Rise
The theme for this year’s International Women’s Day (IWD) on 8th March was ‘Give to Gain’. The campaign...
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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...
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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)...
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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 indicator...
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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 software...
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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. Industry...
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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

Six geese a-laying: CluePoints’ AI predictions for 2026

Returning to the series is CluePoints, with Sophie Henderson, senior strategic consultant, sharing her hopes and...

Source: Discover Pharma

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 highlighted...

Source: International Pharmaceutical Industry

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 quality management...

Source: Discover Pharma

CluePoints Scoops Prestigious 2025 Scrip Award

CluePoints Scoops Prestigious 2025 Scrip Award RBQM and AI leader wins the ‘Best Contract Research Organization...

CluePoints Appoints Steve Young As Senior Vice President Of US Operations

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

CluePoints CEO, François Torche, Honored In PharmaVOICE 100

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has...

CluePoints Risk-Based Monitoring Platform (Version 1.9.0) Is Live!

We’re thrilled to announce that CluePoints’ latest version (1.9.0) of the Central Monitoring platform is live!...

CluePoints Founder, Marc Buyse To Deliver Clinical Trial Data Quality Course At The ASA Biopharmaceutical Workshop

The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is fast approaching and we’re thrilled to announce that...

Unveiling CluePoints’ New And Improved Risk-Based Monitoring Software

Today, we’re thrilled to unveil CluePoints’ latest release of its award-winning Risk-Based Monitoring Software. For this...

CluePoints Announce 2nd Annual Risk-Based Monitoring Roadshows To Take Place In Basel, Switzerland & Cambridge, UK

Join CluePoints CEO Francois Torche and OmniComm Sr. Director Steve Young at this special thought leadership...

CluePoints Named Clinical Research & Excellence Awards Finalist

Awards recognize CluePoints’ Risk-Based Monitoring solution in the ‘Best Sponsor-Focused Technological Development’ category. Cambridge, MA –...

CluePoints And Widler & Schiemann Collaborate On Complete Risk-Management Solution For Clinical Trials In Line With New Industry Guidance

Partnership will combine CluePoints’ Risk-Based Monitoring Software with Widler & Schiemann’s Consultancy Services Cambridge, MA –...

CluePoints Partners with OmniComm Systems® to Offer Collective Risk-Based Monitoring & Electronic Data Capture Solution

Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials,...

CluePoints Announces Partnership with Bracket for CNS Trials

Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials,...

CluePoints Chief Commercial Officer Named in PharmaVOICE 100

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials,...

CluePoints Receives € 6million Growth Investment

Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials,...

Solving the Rubik’s Cube of Competing Forces to Realize the Future of Clinical Research

Artificial intelligence (AI) has massive potential to advance clinical research.

...

Source: DIA

DIA 2023 Topic: The Industry-Wide Definition for RBQM

At the recent DIA 2023 Global Annual Conference, I focused my attention on discussions about the...

Source: Clinical Research News

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