There are a lot of discussions in the clinical trial environment about Remote Site Monitoring (RSM) and related processes. The purpose of this article is simple: outline how RSM can enhance the global productivity — and reduce the costs — of a clinical trial.
A lot has been told on the subject, so let’s try not to be redundant.
First, What Remote Site Monitoring is NOT
Very often, Remote Site Monitoring is confused with another process, namely Risk-Based Monitoring (RBM). RBM is a method utilizing the clinical trial site’s personnel to verify study data and its integrity directly onsite, using the appropriate tools. In this case, the Clinical Research Associate (CRA) no longer needs to spend the time and energy onsite checking data integrity, which can be a tremendously time and money consuming process — especially during a large clinical trial, with multiple study sites.
So, What Is Remote Site Monitoring Then?
RSM allows monitoring activities which were previously conducted on-site to be conducted remotely, increasing efficiency and speeding up time to market. The CRA is still very much involved, but he/she doe not spend time onsite. Instead the CRA performs all the study monitoring processes remotely, using a secure online platform.
Benefits of Both RBM & RSM
The common and major benefit of both RBM and RSM is that the CRA indeed spends much less time, if any, at the clinical sites. When you consider that an average of 30% of the total clinical study budget is spent on CRA sites visits, it is easy to understand why RBM and RSM are quickly becoming key elements of the global study process.
If you are a Sponsor and your Study XYZ has a budget of $300 million, utilizing traditional monitoring techniques with ongoing CRA site visits and you are looking at ~$100 million. By simply adding a Remote Site Monitoring process to the same study — and utilizing a partner that delivers RSM solutions through specialized personnel — you can dramatically decrease that $100 million budget.
