Clinitude is introducing a new revolutionary way of site monitoring.
The last few years the buzz words in the clinical trial industry have been: Risk-Based Monitoring (RBM), targeted monitoring, remote monitoring, and how these innovations increase data quality and reduce costs.
But what exactly will RBM change? How will RBM affect the CRA and the traditional way of monitoring? And how can we adapt to these changes?
Our CRA Liaison service is a game-changing approach that combines the efficiency of targeted and remote data review with the effectiveness of CRAs and site relationships.
Let’s explore how RBM works in three important steps:
Quality by design
The first step is the design of the study.
When developing the study design, the main goal is to remove any unneeded procedures and minimize major operational risks. This is a patient-centered approach.
Planning and Setup
The second key step is the planning and setup of the study.
During this step, Key Risk Indicators (KRI) are assessed and a thorough risk mitigation plan is prepared.
In this stage, the critical data is identified and a dynamic source data verification (SDV) plan is drafted and set up. These key steps form the foundation of the RBM approach.
Execution of the study
The third step of the RBM approach is study execution.
A central team is organized and remote, target monitoring is started – instead of 100% SDV. It is this step that triggered us to develop the revolutionary CRA Liaison model. For many years our experience has been with ‘traditional’ monitoring, and in fact, the whole industry has been trained in a 100% SDV culture. Should we now expect that CRAs know how to handle RBM? What about the quality of site relationships, which can impact trial success? RBM provides oversight on the most important aspects of the trial and subject safety, but until now CRAs have been working with the data in an isolated way.
Our CRA Liaison model solves this problem because it integrates RBM with high quality site management and interaction with cross functional teams.
Role of the CRA Liaison
CRA Liaison - The feedback
“Working together with the CRA Liaison helps me getting an oversight on my sites performance, especially for queries, this is a big additional help for me. The video calls are very interactive and provides me the information I need to prepare for my next visit.”
“In the beginning it was difficult to know there is a team helping me. Now I feel that I even can perform an actual pharmacy visit every monitoring visit that is scheduled.”
“Now I am prepared when the CRA performs the on site monitoring visit. I used to complete the eCRF only a few days before the scheduled monitoring visit.”
“I was impressed by the remote set up. We are a small team and I was afraid that this would be too much to handle but the contrary is happening. Our team is very pleased with the early real time verification of the Clinitude Team.”
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