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A collection of our white papers, case studies & guides

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How CluePoints Enabled Pfizer's 'Hyperspeed' Vaccine Development
Leveraging Risk-Based Quality Management to Facilitate Early Risk Detection
How CluePoints Detected Fraudulent Reporting of Investigational Product Administration from Patient Diary Data
Using CluePoints to Detect Anomalies in Electronic Patient-Reported Outcomes
Using CluePoints to Identify Severe Propagation in Vital Sign Measurements
Using CluePoints to Identify Fraud Due to the Fabrication of Patient Diaries
Using CluePoints to Detect Miscalibrated Equipment in a Clinical Trial
The Value of the CluePoints Solution in Identifying Under-reported Adverse Effects in a Clinical Trial
Using CluePoints to Reveal Protocol Deviations in Patient Selection
Examining the Current State of ICH E6 (R2) Adoption
From RBM to RBQM: The Future of Risk-Based Trial Management
Harnessing CSM to Drive Risk-Based Quality Management (RBQM)
Conclusions from Executive Roundtable on Response to ICH E6 (R2)
The Evolution of Clinical Data Management to Clinical Data Science
Implementing a Scalable Risk-Based Monitoring Strategy
Sponsor Responses to the ICH E6 Revisions
The Principles of Central Statistical Monitoring
Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods
All you need to know about SMART™, the Engine that Drives CluePoints
Therapeutic Innovation & Regulatory Science: Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
Tufts Center for the Study of Drug Development Impact Report: Analysis & Insight Into Critical Drug Development Issues
Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes
The Eradication of False Signals in Monitoring
Statistical Monitoring of Data Quality and Consistency in the Stomach Cancer Adjuvant Multi-Institutional Trial Group Trial
Data-Driven Risk Identification in Phase III Clinical Trials Using Central Statistical Monitoring
The Role of Biostatistics in the Prevention, Detection, and Treatment of Fraud in Clinical Trials
A Statistical Approach to Central Monitoring of Data Quality in Clinical Trials
Centralized Statistical Monitoring as a Way to Improve the Quality of Clinical Data
Linear Mixed-Effects Models for Central Statistical Monitoring of Multicenter Clinical Trials
Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials
A Hercule Poirot of Clinical Research
Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods
Fraud in Clinical Trials: Complex Problems, Simple Solutions?
Impact of On-Site Initiation Visits on Patient Recruitment and Data Quality in a Randomized Trial of Adjuvant Chemotherapy for Breast Cancer
Data Fraud in Clinical Trials
PM360: Clinical Research 2.0 Must Embrace Change
OutsourcingPharma: Women in Science: Dr Laura Trotta - 'I joined CluePoints because of the research but also the mindset'
OutsourcingPharma: CluePoints on overcoming scepticism and the benefits of AI to optimize trial strategies
Applied Clinical Trials: SCOPE 2024: Steve Young of CluePoints Discusses RBQM and Key Risk Indicators
Therapeutic Innovation & Regulatory Science: Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
Clinical Research News: Trendspotting: What’s Coming for Clinical Trials and Research in 2024
Outsourcing Pharma: The key pharmaceutical trends from 2023 according to industry leaders
Applied Clinical Trials: Using Machine Learning and NLP to Improve Central Monitoring Documentation
OutsourcingPharma: CluePoints wins prestigious accolade for commitment to innovation and education
DIA Global Forum: Statistics Powering Risk-Based Quality Management
DIA Global Forum: Solving the Rubik’s Cube of Competing Forces to Realize the Future of Clinical Research
Clinical Research News: DIA 2023 Topic: The Industry-Wide Definition for RBQM
DIA Global: Statistics Powering Risk-Based Quality Management
Clinical Leader: RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)
Applied Clinical Trials: Ukraine War's Impact on Clinical Research: Evidence from Key Risk Indicators
International Clinical Trials: Women in Pharma 2023 | Growing Leadership and Choosing Your Priorities
OutsourcingPharma: CluePoints announces full agenda and speakers for free RBQM event next month
Applied Clinical Trials: ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?
CenterWatch: RBQM Elements Have Seen Limited Adoption in Trials, New Global Survey Finds
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters
OutsourcingPharma: Paving the path for risk-based quality management and sharing insight at DIA Global
OutsourcingPharma: Interview: How CluePoints is making clinical trials 'safer, streamlined and more efficient'
Applied Clinical Trials: Industry Trends: Cycle Time to Resolve Risk Signals
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring
The Role of KRIs in Process-Driven RBQM Success
Quality Tolerance Limits: A Review of Industry Trends
The Role of Transferable Skills and Data Science in the Move to Digitally-Enabled Clinical Research
Identifying Important Risk Indicators in Clinical Development
RBQM: A Natural Evolution to Achieve Gold Standard Clinical Trial Management (Pages 38-39)
Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes
Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes
The Eradication of False Signals in Monitoring
Detection of Atypical Data in Multicenter Clinical Trials Using Unsupervised Statistical Monitoring
Achieving Successful Decentralized Trials by Leveraging RBQM and Centralized Monitoring Oversight
Clinical Research: Causing a Wave of New Career Opportunities
Unlocking the Potential of Risk-Based Quality Monitoring
Risk-Based Quality Management Perfect for DCTS
Why Risk-Based Quality Management Represents the Future of Clinical Research
Managing Clinical Trials Amid the Coronavirus Pandemic
Effective Risk Management When Using eCOA and ePRO
Leveraging Audit Trails to Monitor Clinical Study Risk
Using Statistics to Improve Data Quality and Maximize Trial Success
How ICH E6 (R2) Provides a Win/Win/Win through Risk-Based Study Execution
From RBM to RBx: The Keys to Successful Adoption and Implementation
What Does Risk Mean?
Leveraging Intelligent Analytics to Realize the Full Value of RBx and Compliance with ICH E6 (R2)
FDA Offers Further RBM Guidance Stressing Data Quality Oversight
How SMEs Can Achieve Regulatory Compliance Through a Risk-Based Approach
Update on ICH E6 (R2) Guideline for GCP
A Revolutionary Cure for RBM and Centralized Monitoring
The Bigger Picture of the ICH E6 (R2) – Looking Beyond Compliance
ICH E6 (R2) – Miracle Pill for the Clinical R&D Industry
Empower Clinical Trial Teams with ML
The Risk-Based Data Management Revolution
Your RBQM Benchmark Analysis: Prepare for ICH E6 R3
CluePoints Intelligent Analytics Platform

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Featured Whitepaper

ICH E6 (R2)
Summary
Paper

Created in conjunction with our peers at TUFTS Center for the Study of Drug Development, this paper provides insights on how companies are responding to ICH E6 (R2) and information on the key themes on adoption.

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Featured Webinar

ICH E6 (R2)
Webinar
Series

This recorded webinar covers all of the frequently asked Questions about ICH E6 (R2), Risk-Based Study Execution (RBx) and what’s required from a people, process & technology standpoint.

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We're Kind of a Big Deal.

7,000

Platform Users

1,200

Studies De-Risked

100,000

Issues Detected