Ashok Ghone

Articles

Empower Centralized Monitoring with the Right Mix of KRI and CSM Reports

March 22, 2017

Centralized monitoring is the core of RBM and helps study teams decide on on-site monitoring activities and site intervention. Thus, the right mix of KRIs and Central Statistical Monitoring Reports is crucial for trial success.

Centralized Monitoring for Improving Investigational Sites and Oversight Performance

November 03, 2016

Centralized monitoring is a suitable way in which sites can identify and control investigational risks while improving performance. This new approach can not only help sponsors to monitor site performance, but also facilitate proper oversight resulting in good ROI.

Ensure Sites’ Readiness for New Monitoring Initiatives

August 25, 2016

Investigational sites’ readiness to support new monitoring initiatives such as risk-based monitoring and centralized monitoring will dictate their success. Here are key aspects that sponsors and CROs should establish with investigational sites while implementing these new initiatives.

Risk Identification for Centralized Monitoring

May 24, 2016

Identifying Key Risk Indicators (KRIs) is an important step in successfully applying risk-based monitoring initiatives to a clinical trial. These factors, within risk management, assist by defining risk areas in order to measure and monitor them centrally throughout the trial.

Central Monitor: A Key Driver of Centralized Monitoring

March 23, 2016

With the introduction centralized monitoring in a risk-based monitoring (RBM) approach, the central monitor is emerging as a key and important role.

Implementing an RBM Approach to Clinical Trials: Keeping It Simple

March 04, 2016

Using the five steps to a risk management plan from other industries--Identify, Assess, Plan, Track and Control--to inform a RBM approach in clinical trials.

Centralized Monitoring--A Smart, Reliable Approach

October 01, 2015

The successful implementation of centralized monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place.