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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.

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 grow...
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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’. 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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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

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 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)...

FDA Signs Agreement With CluePoints To Explore A Data-Driven Approach To Quality Oversight In Clinical Trials

Cambridge, MA – FDA and its stakeholders have an interest in assuring the integrity of clinical...

CluePoints Teams Up With Paragon Solutions To Share The Secrets Of Successful Risk-Based Monitoring Implementation

We’re delighted to announce that are our next Risk-Based Monitoring implementation webinar is open for registration!...

CluePoints Announces Locations For Risk-Based Monitoring Implementation Roadshows

The CluePoints and OmniComm Risk-Based Monitoring Implementation Roadshow is Coming to a City Near You! In...

CluePoints Announces Free Risk-Based Monitoring Strategy Review

We’re thrilled to announce that CluePoints is now offering a complimentary Risk-Based Monitoring strategy Check-up and...

DIA Global Forum: Statistics Powering Risk-Based Quality Management

CluePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical...

Source: DIA

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