When it comes to clinical trial planning, it's not only about designing a protocol that will demonstrate the safety and effectiveness of a potential new medicine or device. There are many administrative tasks to accomplish before patient recruitment and enrollment can begin. One of those tasks is building the site budget, which is needed to financially forecast, plan, negotiate, and administer investigator grant payments for each of the research sites running the clinical trial.

Paying sites in a timely, consistent, and reliable manner is not as simple as it may sound, especially with the average number of visits, procedures, sites, and countries per trial continuing to climb. In a new trial, there are multiple stakeholders in functions ranging from medical writing to clinical data management (CDM) to electronic data capture (EDC) that have a significant impact on the budget and payment process – most often without even realizing it, since we all tend to work in silos. For site payments to run smoothly, there needs to be a deliberate effort to bring these functions together, understand how each impacts the other, and agree on a path forward.

At the Summit for Clinical Operations Executives (SCOPE 2023), I participated in a panel discussion with Jenn Hill, Director of Clinical Site Contracting & Payments at Vertex, and Donna Libretti Cooke, JD, Director of Contracting & Budgeting at Bayer, on the topic of budgeting for site payment success. Considering our combined hands-on experience in budget development, negotiations, contracting, investigator payments, and site set-up, we all understood the importance of beginning with the end in mind:

• Medical writing publishes a protocol, with terminology that may vary between therapeutic areas for key terms that trigger payments
• EDC builds the case report forms (CRFs), using field names from the protocol terminology
• CDM parses the information that will feed automated payment systems

Meanwhile, budgeting, negotiating, and contracting with sites are underway, sometimes without the final protocol or EDC being completed. Each country and/or site may use its own specific clinical trial agreement (CTA) wording, introducing additional terms that may not match that of the protocol or the EDC system. These discrepancies are often the reason that payments are delayed.

During our panel discussion, Jenn Hill confessed that now she realizes the mess she must have left for Payments teams to manage when starting out early in her career in budget development. She built budgets without understanding the upstream sources and downstream uses of its components. But this reflection has shaped how she leads her team today to always seek collaboration across the enterprise.

By gathering all stakeholders together to discuss strategies and agree on terminology upfront, many of the glitches that delay payments can be avoided. Other suggestions our panel shared include:

1. For studies with sites around the globe, start with the U.S. budget and then roll out that template globally to ensure consistency. Ask each country to conform with the terminology provided and not change visit names, etc. There are, of course, exceptions for those countries that have mandatory country-specific templates.
2. Automate payments as much as possible through integrations with EDC and clinical financial systems. To minimize manual interventions and workarounds, be sure your payment system is flexible enough to process patient visits, reimbursables, country specifics, and amendments.
3. Ensure sites are aware of what items are paid automatically and what needs to be invoiced, in order to maintain transparency and avoid duplicate payments that are often difficult to reconcile. This is especially important when handling unscheduled visits.
4. Educate sites on best practices for getting paid in a timely manner, such as taking advantage of a self-service portal or other tools that the payments provider may make available. Each study that a site is conducting, even those from the same sponsor, may use a different payments provider, so it requires sites to know which process to follow. Some sponsors such as Bayer are working to give sites a consistent experience across their clinical programs by standardizing on a single payments provider globally.
5. Give sites simple ways to get paid for reimbursables, with either a payments portal to upload invoices or the ability to email invoices to the payments provider. Find ways to minimize conditional invoicing as much as possible.
6. Consider including someone on your budget development team that has clinical expertise. Having more than 20 years’ experience in a medical center before moving into budgeting and contracting, I was able to assist my team in negotiating more accurate budgets with my knowledge of time and effort needed for specific procedures and patient visits.
7. Open lines of communication between site and sponsor stakeholders to prepare for and uncover inconsistencies throughout the trial.

During study start-up, everyone is sprinting toward the goal of that first patient visit. Yet, it’s really just a mile marker in the marathon that is a clinical trial. Prepare for the long run by taking the time upfront to collaborate with team members in medical writing, EDC, and CDM to ensure the CRF and patient visit data is aligned with CTA terms and payments systems. It will make the journey easier for everyone!

You can hear more from Bayer, Vertex, and IQVIA Technologies on the topics of budgeting and payments in these resources:

Sky-High Inflation and the Great Resignation: The Impact on Clinical Site Budgeting

Investigator Payments: A Critical Component in Bayer's Sponsor of Choice Strategy

If you’d like to talk further about this topic, then please reach out to me at OrchestrateYourTrials@iqvia.com.