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.
Making Site Payments is Not as Easy as it SoundsPaying 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.
Begin with the End in Mind – But Where is the Beginning?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:
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.
Confessions of a Budget PlannerDuring 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:
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
Webinar (60-minute webinar) | Executive Summary (10-minute read) |
Investigator Payments: A Critical Component in Bayer's Sponsor of Choice Strategy
Webinar (60-minute webinar) | Executive Summary (10-minute read) |
If you’d like to talk further about this topic, then please reach out to me at OrchestrateYourTrials@iqvia.com.