The clinical trial payment process has long been frustrating for sites as well as sponsors and their CROs, with uncertain invoicing procedures, misunderstandings around payment terms and data entry complications often leading to late, incorrect or missed payments. Add to the picture the trend toward increased trial complexity, adoption of new technologies and the use of decentralized trial (DCT) methods, and all parties are feeling the pinch of payment problems more than ever.

The changing trial landscape is making the site payment process, always a complex undertaking, even more challenging and prone to pitfalls, such as data entry errors in new electronic systems that automatically trigger payments, costs of protocol amendments not accounted for in the original payment plan and confusion around virtual visits that require splitting payments between sites and vendors.

The process is causing enough of a headache for sites that some have declined future trials from sponsors who dropped the ball on site payments or, worse, taken sponsors to court. A recent roundtable meeting sponsored by CRO giant IQVIA brought together around 20 pharma and biotech clinical operations and finance execs to discuss modern-day pain points for sites, with DCT issues taking top billing.

“You’ve got different definitions and budget structures for different types of visits,” said Stuart Thiede, global head of financial lifecycle at IQVIA. “From a site perspective, this is a challenge, because now instead of visit three being a certain amount, it could be one of four amounts,” Thiede said.

The patient visit has diverged into “so many pathways,” Thiede told CenterWatch Weekly. “We used to pay primarily sites; now we may need to pay four to six different vendors for a patient visit.”

For example, a DCT patient visit in a trial might consist of a telemedicine session with the principal investigator, a blood draw by a visiting nurse agency and a user support call with a medical device vendor. This can create a confusing payment arrangement for sponsors and CROs to navigate, as well as a need to update systems that may be a decade or two old.

The vast majority of sponsors outsource site payments to CROs, which adds an extra level of complexity to the process. Working with a CRO intermediary requires effective communication and careful data oversight to keep the payment process running smoothly, according to financial officials at one large site network.

Sarah Cannon Research Institute (SCRI), the oncology arm of HCA Healthcare, works with IQVIA on approximately 250 trials across more than 20 sites, submitting invoices either by email or through its electronic data capture (EDC) system, which transmits the invoice to the CRO for automatic processing.

Having capable teams behind project management and a data-driven approach to identifying payment problems has been critical for the institute when it comes to site payments.

For instance, SCRI recently caught an issue with some sponsors that required certain elements be entered in the EDC for a visit payment to be triggered. The problem, they discovered, was that their clinical trial agreements (CTA) did not outline the percentage of information that needed to be entered in the EDC to initiate a payment, leaving sites unclear on exactly what was needed to get the payments rolling, Tricia Mora, senior manager of revenue cycle for SCRI, explained.

“That criterion isn’t documented in the CTAs or the master agreements, so we don’t necessarily know what it is, what the percentages are,” she said. “This is a recent discovery we’re currently gathering data for to see if we can go back to the sites to educate them and let them know what needs to be done for each payer, study and sponsor to receive payments.”

One of the institute’s biggest issues with CROs handling payments is the practice of taking “clawbacks,” recouping a portion of money already paid to a site, on automatic visit payments, Caroline Hudson, accounting manager for SCRI, said. Specifically, IQVIA makes adjustments to payments it sends to the institute based on rate changes and other things without providing direction on where it’s recouping the differences from, creating significant confusion in some cases.

The institute is currently working with IQVIA to obtain more details on where the money is being taken from, holding weekly meetings to discuss payment-related issues and murky areas, including any open payments, and come up with solutions.

There’s no one-size-fits-all approach to properly setting a site or institution up for clarity and success on site payments, but for SCRI, its clinical trial management system (CTMS) and accompanying accounts receivable component are integral. Together, Hudson and Mora work to ensure their systems are reporting missing payments and granular details on missing items from payments. And behind the CTMS are multiple teams that play an essential part in setting their trials up for proper billing.

“All of our projects are built, created and managed in our CTMS. We have our study activation team, we have a protocol team that actually goes into the system and builds out the shell of that protocol, as well as a budgets team that comes in after them and adds the rate,” Hudson said. “From a collections perspective at Sarah Cannon, we are relying on those upstream teams to ensure that the protocol was built appropriately in our CTMS and that we’re therefore billing appropriately.”

But even with a robust CTMS that keeps up with changes from protocol amendments (and by extension, possible budget amendments), SCRI still runs into problems. At the end of the day, it’s still a study monitor’s responsibility to inform sites when data are missing, but because monitoring visits could happen months after certain data were entered and things could be missed, the systems in place at the site need to be able to capture the data required to trigger payments and catch problems, Hudson says.

“[We’re] leaning on our partnership with IQVIA as well as some other key CRO partners that we have to ensure that we’re updating our processes appropriately, leaning on data and our systems information to guide us on where the gaps are,” she said, and using that partnership to produce as much information as possible to make sure the sites know if something is missing.