This article describes the people, process, and technology important to enable effective Centralized monitoring. By using examples of various models TransCelerate Member Companies have piloted, the article provides workflows for different implementations of Centralized monitoring

This paper describes high-level considerations when designing and building an integrated technology solution that will aid in scaling the RBM methodology across an organization’s portfolio

TransCelerate expanded the initial retrospective analysis that was undertaken as a component of the RBM Position Paper to thoroughly and objectively analyze the value of Source Data Verification (SDV) as a quality control measure in clinical trial execution. The article questions the value of SDV in a trial, and the answer emerges through a comprehensive literature review, a retrospective analysis of data in clinical trials, and an assessment of major/critical findings from audits

This white paper presents functionality details for an integrated RBM technology solution and is an extension from the first Technology Considerations paper from September 2014. The paper is targeted towards sponsors and their representatives as they select and implement a system to perform RBM on, as well as technology vendors as they develop solutions that could support RBM approaches to monitoring

This article is a follow up to Part 1, which was published in September 2014. This paper shares information on what has been learned by various companies’ applications of Centralized monitoring activities based on different RBM operating approaches. The paper specifically provides guidance on what has been learned from the application of the Risk Indicator Library

This paper reports on a survey that was distributed to TransCelerate Member Companies to assess current strategies for detecting and mitigating risks involving fraud and misconduct in clinical trials. Based on blinded survey responses, TransCelerate recommends that companies that elect to use RBM create an integrated, multifaceted approach to proactively detect data quality issues, with detection methods tailored to the characteristics of the study

This paper reports on a TransCelerate-lead study that tested statistical monitoring on a data set from a chronic obstructive pulmonary disease (COPD) clinical study with 178 sites and 1554 subjects. The paper reports on the steps of the trial and recommends a cross-functional, collaborative approach to statistical monitoring that can adapt to study design