Why Remote Monitoring Has Historically Failed in Clinical Trials and How to Keep it from Failing Again as the Industry Pivots to Remote Access During COVID-19.

Remote monitoring is the buzz word of the hour in clinical trials. Rightfully so. As COVID-19 turns clinical operations upside down with restricted site access, the need to turn-on remote site access for start-up, monitoring, and SDV is a top priority for every Sponsor and CRO.

However, the idea of remote monitoring is not new to this crisis. It has been discussed and attempted for over a decade. In fact, in a 2010 published paper by the University of Colorado, the researchers stated: “We hypothesize that remote monitoring will demonstrate substantial improvements in study monitoring efficiency, effectiveness, and possibly overall costs when compared to present monitoring plans that require a prolonged on-site visit by a study monitor from the coordinating center.”[i]

So, if remote monitoring has been the dream for more than a decade, why is it not a reality today?

In short, technology vendors attempting to create a remote site access platform always approached it from the Sponsor and CRO point of view. Major technology providers to the Sponsor and CRO industry knew the value of remotely connecting to research sites, and attempted various solutions over the years – from site portals to FTP platforms, to “free site workspaces.”

None of these solutions delivered the value to make remote site access, monitoring, start-up, and SDV a viable option. Because technology vendors were performing these initiatives at the bequest of the Sponsor and CRO, no one took the time to thoughtfully design the platforms to be easy-to-use, intuitive, and beneficial for the research site.

Research sites, when forced to adopt these tools, found them clunky, hard-to-use, and disruptive to their processes. As a result, over a decade of failed attempts at trying to repurpose Sponsor and CRO technology for research sites left those sites reluctant to adopt new systems to enable remote access.

Now, as COVID-19 reignites the conversation, technology vendors are racing to “be the answer” to remote collaboration. However, much as throughout the last decade, the industry runs the very same risk of Sponsor and CRO-focused technology being hastily “repurposed and repackaged” for sites, resulting in another failed attempt at innovation.

So, what is the answer?

After working with over 7,200 research sites across 26 countries to solve their internal workflows with an eISF and enable remote collaboration, we believe it is all about elevating research sites to be partners in cures. This shift means instead of forcing software on the site, Sponsors and CROs must find innovative ways to integrate with the platforms they already love to use.

Does a site-first approach work? The data says yes. Florence is a site-first solution utilized at 7,200 research sites around the globe, and over the last month we have seen:

  • Over a million remote site access actions across start-up, monitoring, and SDV by Sponsors and CROs took place on the Florence platform in March and April of this year.
  • A top 3 CRO turned-on remote site access at 15 international sites in 3 days, which were previously using paper binders.
  • A major academic medical center on the Florence platform said they are “reevaluating how we work with monitors in the future based on this experience.”

It is no secret that remote site access for start-up, monitoring, and SDV is the future of clinical trial operations. However, for this crisis to serve as a catalyst for innovation that propels the industry in that direction, we must be thoughtful about how we move forward.

Connect with the Florence team to discuss how to turn-on remote site access today.

[i] https://clinicaltrials.gov/ct2/show/NCT01151995

Blake Adams
VP Marketing, Florence