Being Financially Prudent As A Site Isn't a Bad Thing
By Dan Schell, Chief Editor, Clinical Leader
I'm just so busy.
I can't think about another thing.
I'm super slammed.
I cannot add another thing to my plate.
If you work at a clinical trial site — especially a smaller one — you most definitely can relate to all these phrases. So if someone suggests that “finance is everyone’s job!” you likely will roll your eyes and get back to putting out the next fire of the day.
Dr. Daniel Fox hears these types of comments all the time when he audits the finances of clinical research sites. He also hears operational and regulatory team members say things like, “It's not my job to be a part of finance. My job is to take care of the patient,” or “My job is to talk to the IRB.”
Often any talk of optimizing a site’s revenue is seen as being greedy. But the cold truth is, sites are a business, and in order to keep taking care of patients, the site has to, at the very least, cover its costs. Unfortunately, what Fox has seen when working with hundreds of sites in his capacity as the founder/CEO of the Clinical Research Payment Network (CRPN), is that the silos these professionals work in are inadvertently creating huge blind spots that can destroy a site’s finances.
The 3 Pillars Of A Site
To understand this phenomenon, you must look at what he describes as the three pillars (i.e., silos) of a site’s infrastructure. First, there are the site owners and administrators; the ones who run the business and make up the business administration (e.g., contracts, expenses) team. The second pillar is the regulatory team, which engages with regulatory agencies and the IRB. They maintain all the archiving and documents and make sure the site stays regulatory compliant. They are also responsible for things like monitoring visits, protocol amendments, and notifying IRBs of SAEs or AEs. The third pillar is the operational arm, which includes the PI, CRC, and any others who are patient-facing and actually execute the trial’s protocol. “At most of the sites I’ve visited, the priority is operations,” Fox says. “Consequently, that team tends to be viewed as ‘the site’ and everything/everyone else just supports that team.”
Only If You Negotiate It
Next, you have to understand how the site gets paid. How much is autopay (e.g., data entered into an EDC that triggers a payment) and how much is through an invoice. According to Fox, the latter is where much of the money gets left on the table for sites. And much of it comes from those administrative and regulatory pillars because their work is not patient-facing. For example, how much time the regulatory team spends interacting with the IRB has to be captured on an invoice. If there was a monitoring visit, how much time did the regulatory team spend responding to queries or just making sure the CRA had everything they needed? How about the extra time staff have to devote to an FDA audit or responding to an SAE? What about when there’s a protocol amendment that requires patients to be reconsented? According to Fox, these are all invoiceable items, but as he said numerous times during our conversation, “They are only invoiceable if you negotiate them in your contract.”
Poor communication with the operational team also could be the source of lost revenue. Say a site does not have an autopay option or its CTMS isn't capturing expensive procedures or diagnostics such as biopsies, radiology, MRI, or X-rays. “When sponsors carve out those types of big-ticket items in a contract and make them invoiceable, the PI and CRCs need to know,” Fox says. “Sometimes, to get paid, these procedures require specific documentation from the site. The finance team isn't going to have the relationship with, say a radiology center, that can provide all that documentation. Payment is dependent upon the source, which means it's going to be based off of the PI and the CRC. That’s why you must have that solid communication line between the finance and operations teams.”
It All Comes Down To Training And Communication
With proper training on the advantages of a strong communication plan, finance can be a part of everybody's job without staff feeling like they have another task added to their workload. As part of all staffs’ basic education at a site, make sure they understand what items are autopay and what items are invoiceable. They don't need to know details of the contract such as actual costs, just what events or tasks that occur in their daily routine that need to be communicated to one or more of the other pillars.
Part of that education or SOP should include how quickly they relay information to one of the other groups. This is essential because some contracts will have a type of use-it-or-lose-it clause where if something isn't invoiced within 30 to 60 days, the site forfeits the opportunity to invoice for it entirely.
The value of this interdepartmental communication isn’t limited to what a site can charge for, though; it can also help with the bigger issue of the site just getting paid. “Let me give you a good example of why a site’s regulatory and finance teams need to work in tandem to ensure sponsor accountability and rapid revenue cycles,” Fox says. “If a regulatory leader notifies finance that a monitoring visit is being requested, finance can ensure the sponsor has no outstanding bills. If they are financially noncompliant with the CTA, the monitoring visit can be denied.”
Fox reiterates that sites often don’t know what they can charge for or even what their options are when negotiating a contract. Further, he says that they often lose sight of the importance of managing and enforcing a contract, which is especially concerning after all the time and effort they exhaust during the negotiating phase.
“What I’ve found is when you enhance your financial system to a point where it's fluid — and includes good communication — you get paid on time, you optimize what you get from your contracts, and you are able to negotiate lower rates,” Fox says. “So, you're not inflating certain parts to pay for other parts of your business. And all of that makes you a more competitive site.”