Clinical Research Site Reimbursement with CRIO

Clinical research sites now get reimbursed for CRIO nearly half the time, at $2,000 per study

Many clients ask if sponsors will reimburse them for the use of CRIO on their studies. Not long ago the answer was that sponsors sometimes did, but often it was an uphill battle. Now, sponsor reimbursement is becoming commonplace and soon may be the default.

CRIO’s findings confirm that sites who seek reimbursement get it half the time

Across CRIO’s U.S. client base, 27% of all study budgets in the first quarter of 2023 had a specific invoiceable line item to reimburse the research site for their use of CRIO or a related site-adopted technology. When a reimbursement was provided, the average was $2,082.

However, this is not the complete picture. Some sites do not request reimbursement, and some sites require reimbursement, but in a different part of the budget, such as through a higher overhead percentage or a higher startup fee. To extrapolate the true “success rate” for sites that seek reimbursement, CRIO performed two separate analyses.

1. Site analysis

First, CRIO reviewed data for organizations that had a large number of study budgets in the data set to isolate the success of those who appear to be actively seeking reimbursement.

Among 18 organizations that had 10 or more study budgets, CRIO found the following:

• 6 were able to get reimbursed 60% or more of the time,
• 7 were able to get reimbursed roughly 10-40% of the time, and
• 5 had zero budgets with tech related line items.

Here’s a breakdown showing the % success rate by organization:

The five that had zero reimbursement rates were all large, sophisticated networks, on par in every respect with their peers who had positive rates of reimbursement. It’s unlikely that they lacked the negotiating leverage or skill of their peers.

Therefore, it’s reasonable to conclude that they either did not seek reimbursement for technology fees, or folded it somewhere else in the budget.

When this subset is excluded, the data shows:

• 47% of budgets have a line item reimbursing the organization for site technology.
• The average reimbursement amount is $2,012.

When factoring in the 53% of budgets that did not have technology reimbursement, the overall budget average becomes $947.

2. Study analysis

Second, CRIO reviewed data for studies that had multiple sites on it to see what percent of studies offered reimbursement for site technology to at least one site on the study. This is an indicator of the potential success rate for any site seeking reimbursement.

The following chart shows the results of the 22 studies that had 5 or more sites on the study. 

45% (10 out of 22) of the sites reimbursed at least one site for site technology fees – this percent is nearly identical to the 47% success rate the site-based analysis showed.

Across all sites, the overall success rate among this subset of studies is 26% – very close to the 27% overall success rate for the entire database.

Taken together, CRIO’s analysis suggests that up to half of sponsors are willing to reimburse sites for technology use, although not all sites seek reimbursement, and when they do, the average fee is a little over $2,000.

What’s behind this trend?

Sponsors are increasingly recognizing the benefits that site-technologies bring to their own studies. CRIO’s own research has shown – consistently – that sites who adopt eSource will have 40% fewer protocol deviations, 70% lower FDA audit risk, and 40% higher enrollment.

The benefits noted above do not even account for the direct benefits to the CRO from being able to perform remote monitoring as needed. For instance, one study team at a major CRO leveraged the remote monitoring capability enabled by their CRIO sites during the pandemic to post the highest monitoring productivity metrics within the CRO.

“Five years ago, we had CRAs telling us that we weren’t allowed to use CRIO,” said Luke Snedaker, CEO of West Clinical Research, and a long-time user of CRIO. “That all changed during the pandemic. Now, we are able to get reimbursed most of the time.”

“By using CRIO, we deliver significant value to our sponsor clients,” said Takoda Roland, Associate Director of Clinical Operations of Sitero, a CRO that distributes CRIO eSource to sites on an opt-in basis. “CRIO allows our monitoring team to review the data continuously, letting us prevent deviations from recurring and improving patient safety.”

This is great news for sites, and the industry as a whole

As protocols get more complicated and decentralized trials add more complexity to operations, it’s imperative for sites to become tech-enabled to manage this increasing inefficiency. When they do, all data shows that all stakeholders benefit. Sponsor subsidization is a clear signal to sites that they understand the benefits of site technology.

When doing a cost-benefit analysis, sites can now confidently underwrite partial offsets from sponsor reimbursement. For sites considering CRIO’s technology (as our analysis is limited to CRIO site experience), they can assume they will be reimbursed, on average, $1000 per study. It’s also reasonable to assume that the rate and amount of this reimbursement will only increase in the years to come.

Methodology

CRIO downloaded every study-level invoiceable fee that was recorded in a budget associated with studies that had a start date in the first quarter of 2023 (U.S. sites only). There were 787 unique study budgets in total, after removing test, validation and other “non-real” studies.

Our staff reviewed each invoiceable fee and identified those that related to use of a site-adopted solution. We only included fees that unambiguously referred to a site-adopted technology.

Most of the fees described the technology very clearly as a variation of a “CTMS”, “eSource” or “eRegulatory”. Common fees included: “CTMS fee”, “CTMS Set up”, “CTMS Implementation”, “CTMS/eSource Technology Fee”, “E-Source Creation Fee”, “eSource/eRegulatory Fee” “eDocument Setup Fee”, or “eRegulatory Activation Fee”. Others simply used the generic moniker “Technology”, as in “Technology Start-Up”, or “Site Technology Fee”. A few characterized the fee in terms of remote monitoring benefits: “24/7 Monitor Access”, “EMR Access Fee”, “Remote Access Fee”.

If anything, CRIO’s analysis likely undercounts the degree of sponsor reimbursement success, as we are not able to capture those instances in which a site was able to get a higher overhead percent, or a higher startup figure, through inclusion of their technology costs. Our analysis is limited only to specific invoiceable line items explicitly tied to use of technology; these items are almost certainly incremental to any other budgetary line items.