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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.

How AI and Advanced Statistics Are Helping Research Rise
Clinical trials are undergoing a period of change. Innovative uses of artificial intelligence (AI) are...
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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...
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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 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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CluePoints Announces Amit Patel as New CFO

King of Prussia, PA: RBQM leader, CluePoints, has today announced that Amit Patel will join as...

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

Citeline Finalist CluePoints Show Advanced AI Capabilities

King of Prussia, PA – March 23rd, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

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

HiRO and CluePoints Partnership Offers Market-Leading RBQM Opportunities in China

King of Prussia, PA: Harvest Integrated Research Organization (HiRO), a Shanghai-based Clinical Research Organization (CRO), has...

CluePoints Wins Scrip Award for Clinical Advance of the Year 2021

CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical...

CluePoints Chief Scientific Officer to Speak at CNS Summit Next Month

Steve Young, Chief Scientific Officer at CluePoints, will take to the podium at this year’s CNS...

CluePoints SVP of Business Development to Speak at Clinical Trials Europe

John Hall, SVP Business Development at CluePoints will share insights into the dimensions of risk associated...

CluePoints Shortlisted for Multiple Awards in Recognition of Pioneering Risk-Based Quality Management Solution

King of Prussia, PA: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality...

CluePoints Chief Scientific Officer And Pfizer’s Global RBM Program Lead To Speak At #CQOF2021

Join us at #CQOF2021! As well as hosting a booth at the Clinical Quality Oversight Forum...

Will ICH E6 (R3) Unleash The Potential Of Risk-Based Trials?

Researchers have been slow to fully adopt innovations designed to overcome the challenges to modern day...

CluePoints Partners With ZS To Provide Best-In-Class RBQM Expertise And Technology, Increasing Clinical Trial Efficiency And Improving Patient Outcomes

CluePoints, the premier provider of Risk-Based Quality Management software for clinical trials, has partnered with ZS,...

Introducing CluePoints’ Post-COVID Trial Assurance Solution

For well over a year now, the clinical research community has been hard at work to...

Revealing The Bigger Picture Through Metadata & Building RBQM Standards Of The Future

Risk-Based Monitoring (RBM) is the future of clinical trials. Yet, despite significant progress in recent years,...

CluePoints Sponsors RBQM Live, The Definitive Guide To RBQM For Experts And Beginners

Have you heard the news? CluePoints is sponsoring RBQM Live on behalf of the industry! The...

Centralized Monitoring: Effective Technology & Documented Evidence Are The Perfect Double Act

If it isn’t documented, it didn’t happen. This mindset has shaped the way clinical monitoring activities,...

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

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