Providing remote monitoring capability used to be somewhat optional, though even before the pandemic, an increasing number of sponsors were already expecting sites to have an eSource system with remote monitoring capabilities before considering them for a study. Fast forward to today and you may have already had to enable some form of remote access for remote monitors, even without the right tools. For sites without a full function eSource system, this can generate a heavy burden of data preparation time and cost for a site just to save sponsors a significant amount of their effort.
The current scenario
A full function eSource system with remote monitoring capability is now a necessity, not just an option! Luckily, an eSource system can also make the data preparation almost effortless when compared to using a collection of existing tools. All in, an eSource system is capable of saving a considerable amount of money for both your organization and a sponsor you may be negotiating with. In fact, since sponsors typically spent 40-50% of their budgets on monitoring visit costs before the pandemic, there was already a real possibility for them to cover some of the costs.
What can be done?
What you need is an eSource solution that gives you total control of remote monitoring access to your site and provides easy workflows for optimizing data preparation and approval. It should also increase savings while maximizing the quality of the information collected. What really makes the difference in remote monitoring is going beyond simple file sharing, which requires a lot of cumbersome paper and digital file preparation to support it, to self-checking digital workflows that constantly communicate status and reduce the file preparation effort. Simultaneously, eSource provides secure, role-based access and eSignature capability throughout the process.
The right kind of eSource system will provide the following:
- Intuitive dashboards summarizing information tailored to the tasks of the remote monitor upon login.
- Streamlined monitor workflows that ease transitions from other systems, eliminating extended learning curves.
- Complete control for your site over what a remote monitor sees, helping to ensure regulatory compliance.
- Reduced risk and better CTMS integration with solutions from a single supplier, especially a market leader.
- Increased efficiency with the ease of data preparation for remote monitoring.
- Training and support for site users that can be extended to monitors if desired.
With sponsors increasingly requiring that sites have an eSource system with remote monitoring capability, it’s quite reasonable to assume you can include related technology costs and coordinator time as passthrough startup costs. It will also make capturing visit data with the “new normal” much easier.
With a “new normal” on the horizon for clinical research sites, remote monitoring is here to stay. If sponsors expect to avoid the risk and costs of in-person visits, it makes perfect sense for them to cover most of the cost for you to offer real-time remote monitoring through a CTMS integrated eSource system. The “icing on the cake” is also a dramatic increase in the quality of the data submitted, which makes everyone happier.
By simplifying and streamlining source data capture and related quality assurances workflows, an eSource system seamlessly integrated with a CTMS will significantly increase the efficiency of data capture, query management and eSignature workflows in support of streamlined remote monitoring and final approvals. In addition, the reduction or elimination of physical monitoring visits provides savings on related expense for your site and significant savings for sponsors.