Remote Trial Site Monitoring Is Permanent. Now What?
If you listen, you can hear it across the industry: the job of the Clinical Research Associate (CRA) and the business of the Contract Research Organization (CRO) have permanently changed.
Crisscrossing the country from site to site is going the way of the buggy-whip, as more sites install their own systems for remote monitoring and sponsors increase the capabilities of their data monitoring.
The logical and economic benefits of remote monitoring were clear long before the pandemic.
To use one executive’s analogy, in a world with online banking, on-site monitoring of paper records each visit is like balancing your checkbook with pen and ink in expectation of your paper bank statement.
Why do that today when you can just see your bank balance on your phone? Why monitor in person when you can see the site’s data and digital documents on your phone, too?
What factors drive this permanent change?
Yet stakes are high in our industry, and an abundance of caution makes change slow.
The pandemic changed this, first with a shock—sites closed their doors to outsiders during its peak. But that initial shock gave way to three irreversible changes:
- Sites don’t want a parade of monitors. Monitoring visits create disruption and take time away from patients. Monitoring visit prep creates an additional workstream outside of core study work.
- Agencies are adjusting their guidance to empower remote work.
- There is a CRA shortage, and rising CRAs are demanding less travel than ever before.
New remote business models for CROs
The addition of remote work is now permanent, and technology for remote patient and site access is a bigger proportion of pharma R&D spend than ever before. This creates a challenge in the C-suite of CROs, because 30-40% of CRO revenue stems from on-site monitoring fees.
But the permanent state of remote site monitoring is actually good news for the CRO industry.
Progressive CROs are creating new monitoring products. The industry is beginning to talk about “continuous monitoring” instead of site visits. By using applications like electronic Investigator Site files (eISFs) that are always on at the site, CROs can offer new services that provide 24/7 monitoring and data flow.
Sponsors no longer have to wait eight weeks for a monitoring visit to understand what’s happening at a site. Instead, CRA teams can provide dashboards that offer always-on visibility and the ability to monitor tasks and content in small bites over time—creating a better snapshot of what’s happening at the site. Visibility improves in the process. Think about the difference between a 4K HDTV and your set from the ‘90s.
Not only do continuous service offerings create better site visibility for sponsors, but they solve two big business problems for the CRO:
- Continuous remote monitoring creates subscription revenue that replaces unpredictable site visit revenue.
- Continuous monitoring provides flexibility in workload – allowing CROs to better distribute work in a tight labor market.
New types of jobs
Speaking of a tight labor market, continuous remote monitoring enables a more efficient distribution of tasks. Site file and document management work can be distributed from central, specialized organizations.
We’ll see the rise of the Clinical Trial Associate (CTA) – a junior, centralized role that can be the first stop for many on the way to a CRA job. This centralization and flexibility allows CROs to manage CRA utilization more effectively and take on more studies.
The result
Continuous remote monitoring using site technologies like the eISF is starting to deliver new levels of performance for the industry.
Site inspection readiness improves because teams can see problems sooner. Sponsor agility improves because site performance is observable through dashboards at all times. Lastly, the CRO business will improve with new subscription-based revenue streams and new approaches for managing CRA utilization rates.
As Lauren Litzinger, Executive Director of Global Site and Study Operations and the Monitoring Business Process Owner for Pfizer, says, “(During the pandemic) we had to lean on technology, such as WebEx and Zoom and Florence, a digital platform for data sharing.”
Ultimately, we’re seeing the industry continue to move in the direction pioneered by Pfizer during the pandemic in order to enhance quality, improve site performance resolution, and get more cures to market, faster.