Publications

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Detection of Atypical Data in Multicenter Clinical Trials Using Unsupervised Statistical 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
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

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ICH E6 (R2)
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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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