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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.

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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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Trendspotting: Embracing AI, DEI Changes, Restrategizing Research Sites
To kick off 2026, we spoke with industry experts and leaders in the Clinical Research News community...
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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...
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Six geese a-laying: CluePoints’ AI predictions for 2026
Returning to the series is CluePoints, with Sophie Henderson, senior strategic consultant, sharing her...
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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...
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  • Press Release
FDA Extends CRADA With CluePoints To Further Explore A Data-Driven Approach To Quality Oversight In Clinical Trials

KING OF PRUSSIA, PA– FDA and its stakeholders have an interest in assuring the integrity of...

  • Featured Article
From RBM to RBx: The Keys to Successful Adoption and Implementation

The latest version of the Good Clinical Practice (GCP) quality standard insists that sponsors implement a...

Source: Global Forum

  • Press Release
ICH E6 (R2) Compliance Webinar Series Available To Watch Now!

“I KNOW ICH E6 (R2) COMPLIANCE INSISTS ON A RISK-BASED APPROACH TO RUNNING MY TRIALS, BUT...

  • Featured Article
Detection of Atypical Data in Multicenter Clinical Trials Using Unsupervised Statistical Monitoring

A risk-based approach to clinical research may include a central statistical assessment of data quality.

...

Source: Sage Journals

  • Press Release
Parexel Strengthens Risk-Based Monitoring Offering With CluePoints’ New Advanced Statistical Capabilities

Strategic collaboration leverages CluePoints’ Central Statistical Monitoring (CSM) technology to enhance data quality and reduce operational...

  • Featured Article
Leveraging Intelligent Analytics to Realize the Full Value of RBx and Compliance with ICH E6 (R2)

Not only is there a significant good clinical practice (GCP) expectation, Risk-Based Monitoring (RBM) presents a...

Source: Contract Pharma

  • Press Release
CluePoints Experiences Continued Rapid Growth As Demand For RBx Rises

WAYNE, PA – April 09, 2019: CluePoints, a leading provider of Risk-Based Study Execution(RBx) and Data...

  • Featured Article
FDA Offers Further RBM Guidance Stressing Data Quality Oversight

Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a...

Source: Outsourcing Pharma

  • Press Release
New! Registration Open For CluePoints’ RBM Roadshows – Pick From San Francisco Or La Jolla!

We’re delighted to announce that registration for CluePoints’ US Risk-Based Quality Management Roadshow is now open....

  • Featured Article
How SMEs Can Achieve Regulatory Compliance Through a Risk-Based Approach

Since the introduction of the ICH E6 (R2) addendum, the industry has seen a rise in...

Source: Pharma Focus Asia

  • Featured Article
Update on ICH E6 (R2) Guideline for GCP

The ICH E6 R2 Addendum is starting to have a significant, positive impact on clinical trial...

Source: Contract Pharma

  • Featured Article
A Revolutionary Cure for RBM and Centralized Monitoring

In the clinical trials industry there is a tendency to watch and wait, which has been...

Source: PharmaIQ

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
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,...

  • Press Release
Introducing CluePoints’ Post-COVID Trial Assurance Solution

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

  • Press Release
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,...

  • Press Release
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...

  • Press Release
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,...

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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...

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Source: Springer Link

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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