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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...
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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...
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SCOPE 2024: Steve Young of CluePoints Discusses RBQM and Key Risk Indicators
In an interview with ACT editor Andy Studna at SCOPE, Young, Chief Science Officer, CluePoints discusses...
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Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
Central monitoring aims at improving the quality of clinical research by pro-actively identifying risks...
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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...
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Trendspotting: What’s Coming for Clinical Trials and Research in 2024
We spoke with leaders and experts in the Clinical Research community about their predictions for 202...
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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...

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

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...

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.

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Source: Sage Journals

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...

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

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...

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

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....

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

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

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

Risk-Based Monitoring Software for Operational Data Analysis

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

CluePoints Announces U.S Patent Allowance for SMARTâ„¢ Engine

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

CluePoints’ CSM Solution with Oracle Health Sciences Cloud Can Enable Proactive RBM and Improve Data Quality

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

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