RESEARCH & THOUGHTS
Perspectives Shaping Clinical Development
Discover engaging resources driving the conversation forward and on-demand demo videos showcasing the very solutions forming the future of our field.
- Guide
Empower Clinical Trial Teams with ML
- Guide
The Risk-Based Data Management Revolution
- Guide
Your RBQM Benchmark Analysis: Prepare for ICH E6 R3
- Guide
CluePoints Intelligent Analytics Platform
- Research Paper
Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
- Research Paper
Tufts Center for the Study of Drug Development Impact Report: Analysis & Insight Into Critical Drug Development Issues
- Research Paper
The Eradication of False Signals in Monitoring
- Research Paper
Statistical Monitoring of Data Quality and Consistency in the Stomach Cancer Adjuvant Multi-Institutional Trial Group Trial
- Research Paper
Data-Driven Risk Identification in Phase III Clinical Trials Using Central Statistical Monitoring
- Research Paper
The Role of Biostatistics in the Prevention, Detection, and Treatment of Fraud in Clinical Trials
- Research Paper
A Statistical Approach to Central Monitoring of Data Quality in Clinical Trials
- Research Paper
Centralized Statistical Monitoring as a Way to Improve the Quality of Clinical Data
- Case Study
Achieving Success in a Phase 3 Dermatology Study with the Power of Effective RBQM
- Case Study
Using CluePoints to Reveal Protocol Deviations in Patient Selection
- Case Study
The Value of the CluePoints Solution in Identifying Under-reported Adverse Effects in a Clinical Trial
- Case Study
Using CluePoints to Detect Miscalibrated Equipment in a Clinical Trial
- Case Study
Using CluePoints to Identify Fraud Due to the Fabrication of Patient Diaries
- Case Study
Using CluePoints to Identify Severe Propagation in Vital Sign Measurements
- Case Study
Using CluePoints to Detect Anomalies in Electronic Patient-Reported Outcomes
- Case Study
How CluePoints Detected Fraudulent Reporting of Investigational Product Administration from Patient Diary Data
- Case Study
Leveraging Risk-Based Quality Management to Facilitate Early Risk Detection
- Case Study
How CluePoints Enabled Pfizer’s ‘Hyperspeed’ Vaccine Development
- Whitepaper
Examining the Current State of ICH E6 (R2) Adoption
- Whitepaper
From RBM to RBQM: The Future of Risk-Based Trial Management
- Whitepaper
Harnessing CSM to Drive Risk-Based Quality Management (RBQM)
- Whitepaper
Conclusions from Executive Roundtable on Response to ICH E6 (R2)
- Whitepaper
Implementing a Scalable Risk-Based Monitoring Strategy
- Whitepaper
Sponsor Responses to the ICH E6 Revisions
- Whitepaper
The Principles of Central Statistical Monitoring
- Whitepaper
Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods
- Whitepaper
All you need to know about SMART™, the Engine that Drives CluePoints
- Research Paper
Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
- Research Paper
Tufts Center for the Study of Drug Development Impact Report: Analysis & Insight Into Critical Drug Development Issues
- Research Paper
The Eradication of False Signals in Monitoring
- Research Paper
Statistical Monitoring of Data Quality and Consistency in the Stomach Cancer Adjuvant Multi-Institutional Trial Group Trial
- Research Paper
Data-Driven Risk Identification in Phase III Clinical Trials Using Central Statistical Monitoring
- Research Paper
The Role of Biostatistics in the Prevention, Detection, and Treatment of Fraud in Clinical Trials
- Research Paper
A Statistical Approach to Central Monitoring of Data Quality in Clinical Trials
- Research Paper
Centralized Statistical Monitoring as a Way to Improve the Quality of Clinical Data
- Research Paper
Linear Mixed-Effects Models for Central Statistical Monitoring of Multicenter Clinical Trials
- Research Paper
Linear Mixed-Effects Models for Central Statistical Monitoring of Multicenter Clinical Trials
- Research Paper
Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials
- Research Paper
Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods
- Blog
ICH E6 R2 – The Clinical R&D Industry’s Response
- Blog
Beyond Risk-Based Monitoring: How Intelligent Analytics Are Being Used To Drive Value And Support ICH Compliance
- Blog
The Bigger Picture Of ICH E6 R2: Looking Beyond Compliance
- Blog
ICH E6 R2: Talking Big Pharma’s Response To The Addendum
- Blog
ICH E6 R2 Roundtable Review – What Does This Mean For The Industry?
- Blog
ICH E6 R2: Waiting And Watching No Longer An Option When It Comes To Risk-Based Monitoring
- Blog
ICH E6 (R2) – Miracle Pill For The Clinical R&D Industry
- Blog
ICH E6 Rev 2 – Ask The Experts
- Blog
Webinar Recording: What Does ICH E6 R2 Mean For Me And My Company?
- Blog
6th Annual CROWN Congress: Sessions You Can’t Afford To Miss + 15% Discount Code
- Blog
Six Ways To Get The Most Out Of Outsourcing In Clinical Trials West Coast ‘17
- Blog
The FDA Is Knocking At Your Door – Are You Ready For An FDA Site Inspection?
- Demo Video
Site Profile & Oversight Tool (SPOT)
- Swiftly pinpoint anomalies and translate insights into actionable strategies with adaptive site monitoring.
- Demo Video
Business Intelligence (BI)
- Explore clinical and operational data from various perspectives and domains in configurable formats with multiple data widgets.
- Demo Video
Central Statistical Monitoring
- Test all collected data, including both clinical and operational, exposing atypical patterns that indicate challenges.
- Demo Video
Duplicate Patients
- Specify configurable variables likely to indicate duplicates and review based on similarity scores and side-by-side evaluations.
- Demo Video
Key Risk Indicators (KRIs)
- Rank sites based on performance and tolerance metrics, uncovering ‘at-risk’ locations in need of corrective action.
- Demo Video
Patient Profiles
- Flag atypical patient patterns, prioritize investigations into anomalies within data sets, and determine critical targets.
- Demo Video
Quality Tolerance Limits (QTLs)
- Identify systematic issues, monitor key metrics, and document deviations from pre-defined QTLs to ensure compliance.
- Demo Video
Risk Assessment & Mitigation
- Determine vulnerable trial areas, define risk controls, and monitor capabilities to detect evolving threat levels.
- Demo Video
Signals & Actions Tracker
- Assess identified issues, annotate commentary, deploy automatic auditing, and leverage extensive exporting capabilities.
- Fact Sheet
Medical & Safety Review (MSR)
- Fact Sheet
RBQM Implementation Tip Sheet
- Fact Sheet
Risk-Based Quality Management (RBQM)
- Fact Sheet
Site Profile & Oversight Tool (SPOT)
- Fact Sheet
Intelligent Medical Coding
- Fact Sheet
CluePoints Overview
