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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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The Negative Impact of Failing to Implement Risk-Based Quality Management
As an industry, we regularly discuss the benefits of adopting risk-based quality management (RBQM). The...
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There’s No Such Thing as Too Much Data
François Torche dispels the myth that, at least in RBQM, there is such a thing as too much data, and...
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Using RBQM and New Technologies to Enhance Data Analysis and Enable Faster Review and Decision Making
An increase in clinical trial data is driving demand for enhanced clinical trial processes. Sponsors...
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Advancing Technology in Clinical Trials
With increasing pressure to overcome drug development challenges and advance drugs to market faster and...
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CRO Industry Report
Today’s drug development landscape demands contract research organizations (CROs) provide flexible models...
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DIA 2024: Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM
In an interview with ACT editor Andy Studna at DIA 2024, Hughes, co-founder and chief commercial officer...
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  • Featured Article
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

  • 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.

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Source: International Clinical Trials

  • Press Release
RBQMLive, Sponsored by CluePoints, Wins Prestigious Sales and Marketing Award

King of Prussia, PA – August 9, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • 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

  • Press Release
Expert Speaker Lineup Revealed for Award Winning RBQM Event

King of Prussia, PA – August 1, 2023: CluePoints, the premier provider of Risk-Based Quality Management...

  • 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

  • Press Release
CluePoints, Ken Getz & Tufts CSDD and PwC Unveil New RBQM Insights Report at DIA Global Annual Meeting 2023

King of Prussia, PA – June 20, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • Press Release
CluePoints Supports Launch of RBQM Live 2023 as Premier Event Sponsor

King of Prussia, PA – May 3, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

  • Press Release
CluePoints Announces Amit Patel as New CFO

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

  • 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

  • Press Release
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...

  • Press Release
CluePoints CEO, François Torche, Honored In PharmaVOICE 100

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

  • Press Release
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!...

  • Press Release
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...

  • Press Release
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...

  • Press Release
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...

  • Press Release
CluePoints Named Clinical Research & Excellence Awards Finalist

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

  • Press Release
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 –...

  • Press Release
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,...

  • Press Release
CluePoints Announces Partnership with Bracket for CNS Trials

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

  • Press Release
CluePoints Chief Commercial Officer Named in PharmaVOICE 100

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

  • Press Release
CluePoints Receives € 6million Growth Investment

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

  • Featured Article
Using Statistics to Improve Data Quality and Maximize Trial Success

Poor quality data has the potential to destroy the validity of a clinical trial, wasting precious...

Source: Tufts Center for the Study of Drug Development

  • Featured Article
How ICH E6 (R2) Provides a Win/Win/Win through Risk-Based Study Execution

Participant safety is the clinical trial sector’s top priority – and striving to achieve this laudable...

Source: Applied Clinical Trials

  • 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

  • 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

  • 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

  • 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

  • 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

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