News

Latest Industry Updates

From company milestones to industry breakthroughs, uncover the stories making waves and shaping the narrative in real time.

Press Release Category Icon
CluePoints and Tufts CSDD Publish Peer-Reviewed Evidence Quantifying the Financial Value of RBQM
New research demonstrates RBQM-enabled trials achieve up to 23x ROI and 19% shorter phase durations,...
Read
Featured Article Category Icon
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...
Read
Featured Article Category Icon
How AI and Advanced Statistics Are Helping Research Rise
Clinical trials are undergoing a period of change. Innovative uses of artificial intelligence (AI) are...
Read
Featured Article Category Icon
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...
Read
Featured Article Category Icon
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...
Read
Featured Article Category Icon
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...
Read
1 2 3 4 … 34
  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Press Release
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...

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Featured Article
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

  • Press Release
CluePoints Scoops Prestigious 2025 Scrip Award

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

  • Press Release
CluePoints Data and Knowledge Manager Appointed to ACT Editorial Advisory Board

King of Prussia, PA – November 5th, 2025: CluePoints, provider of leading statistical and AI-driven software...

  • Press Release
CluePoints Wins Growth Award at BVA Private Equity Awards

King of Prussia, PA – October 23rd, 2024: CluePoints, provider of leading statistical and AI-driven software...

  • Press Release
CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review

CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency with this latest...

  • Press Release
CluePoints Continues ‘Turning Artificial Intelligence into Human Intelligence’ by Launching Two New Innovations

Site Profile & Oversight Tool (SPOT) and Intelligent Medical Coding (IMC) unveiled by RBQM innovator at...

  • Press Release
CluePoints, a Leading Provider of AI-Driven Software Solutions for Clinical Data Review, Receives Significant Investment for Continued Growth from EQT

CluePoints is a cloud-based software platform for Risk-Based Quality Management (“RBQM”) and data quality oversight in...

  • Press Release
CluePoints Brand Evolution Confirms Commitment to ‘Turning Artificial Intelligence into Human Intelligence’

KING OF PRUSSIA, Pa., — CluePoints, provider of leading statistical and AI-driven software solutions, today unveiled...

  • Press Release
FDA And CluePoints Sign New 3 Year Cooperative Research And Development Agreement To Assess Data Quality Using Statistical Modelling And Machine Learning

King of Prussia, PA: CluePoints, providers of leading statistical and AI-driven software solutions and Food and...

  • Press Release
CluePoints’ Site Profile & Oversight Tool (SPOT) shortlisted as finalist in 2024 Citeline Awards

King of Prussia, PA – March 25, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

  • Press Release
Scope of Industry Risk-Based Quality Management (RBQM) Adoption Revealed

King of Prussia, PA: A comprehensive assessment of risk-based quality management (RBQM) adoption has revealed that...

  • Press Release
CluePoints’ Audit Trail Review Project Wins Award for Innovation in the Management of Clinical Data Award

King of Prussia, PA – March 5, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

  • Press Release
Game-Changing ‘Audit Trail Review’ Application Secures ACDM 2024 Awards Nomination for CluePoints

King of Prussia, PA – February 6, 2024: CluePoints, providers of best-in-class statistical and AI-driven software...

  • Press Release
CluePoints wins SCRIP Awards for Best Contract Research Organization (CRO): Specialist Providers

King of Prussia, PA – October 17, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • Press Release
Pioneering AI solutions and a commitment to industry-wide RBQM advancement secures CluePoints a finalist position in the 2023 SCRIP Awards

King of Prussia, PA – October 12, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • 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...

  • Read

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