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Using Remote Clinical Research Site Monitoring During COVID-19

By: Complion

The healthcare and life sciences industry is on a mission to push towards healthier, longer lives for everyone. During a pandemic, this mission still holds true.

Healthcare and life sciences are on the frontlines of the coronavirus — whether it’s directly caring for patients or behind the scenes researching a vaccine or hopefully a cure. The work we all do, and our ability to continue doing it, will be critical in determining exactly how the situation we’re facing today plays out.

COVID-19’s Impact on Healthcare & Life Sciences

During this time of uncertainty, some sites may need to hold operations entirely. For other sites, the burden of work is much higher and more pressing than ever. Some might be involved in upcoming COVID-19 trials, while others are trying to continue the trials that can’t afford to stop even with strict practices of social distancing and quarantining.

Here are some of the challenges that research sites and monitors are facing right now – and how they can overcome them with remote monitoring.

  • Monitors on Hold. Many sites are cancelling monitor appointments, or spending countless hours on the phone with monitors. But every minute talking on the phone (or holding monitor work completely) takes us away from achieving our goals. When it comes to regulatory documentation, monitors should be able to review that documentation without having to interrupt the research coordinators’ work.
  • Limited Onsite Staff. Many hospitals are only allowing essential staff onsite during this time. Also, in order to follow regional quarantine or distancing orders, a number of sites are encouraging staff to work remotely or work with patients remotely. But they still have important documents that have to be managed, updated, shared and signed to move the work along. CVs that need updating or protocol trainings that need to be completed. With remote monitoring, clinical or regulatory staff can get work done digitally – including getting compliant signatures.
  • Other Research on Hold. Unfortunately, some sites have had to slow work or put research on hold entirely. Even though there’s not much these sites can do about this, there is something they can do to prepare for the future. When this pandemic is finally controlled, many of these sites will face an onslaught of work. Now is a good time to implement tools that can help you handle future workloads.

Leveraging eRegulatory to Enable Remote Monitoring

For those whose work can’t stop (whether it’s COVID-19 related trials or not), there is a way to keep up – remotely.

One major burdensome area of clinical research is regulatory documentation. For many organizations, the incoming stream of documents that require printing, routing, signing and filing is never-ending. But with an eRegulatory system that meets CFR 21 Part 11 requirements, research organizations can move to remote monitoring, improving efficiency and reducing redundancy in the process.

What is Remote Monitoring?

With remote monitoring, a clinical research associate never physically goes to the research clinic to conduct monitoring visits. Instead, the monitor reviews data through secure electronic workspaces. While this type of work has become more popular in life sciences in recent years, it’s virtually exploding in light of current events.

A solid eRegulatory solution can help organizations:

  • Easily import documents from scanners, email or digital sources.
  • Search and access documents instantly from all relevant electronic binders.
  • Standardize naming conventions, view activity and modification history, and control individual user access levels.
  • Easily share and unshare documents.
  • Assign tasks within the system and see all document activity.
  • Provide remote view-only access to monitors.
  • Provide all staff access to documents from anywhere with internet.
  • Perform compliant signatures from mobile devices.

Within one system, monitors and site coordinators can perform regulatory work no matter where they are located.


Whether preparing for the onslaught of work after holding operations or trying to find ways to just do the work you can do, remote monitoring is worth exploring – especially when there’s never been a better time to easily implement it.

During this time, Complion has begun completely remote implementations to keep everyone safe but get organizations quickly up and running with eRegulatory software that empowers remote monitoring. Schedule a demo to learn more.

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