At this year's DIA, I presented information about the pain points that the clinical trials industry is experiencing with regards to site payments as well as the trends that are currently occurring in this space – based on surveys, interviews and analysis of data in Bioclinica's Site & Patient Payments technology. One of these surveys was distributed by FierceBiotech in April, in which we asked sponsors about their challenges and experiences with site payments (149 sponsor companies completed the survey). In this blog post, I'll discuss these pain points felt by sponsors as well as some of the industry trends, including payment automation, that can help address these issues.
Typical Industry Site Payment Process
Despite the increasing use and integration of technology in clinical trials, our payment processes continue to be hampered by multiple steps, resources and systems. The Clinical Operations teams typically review a large volume of contracts, each with their own unique terms; manually verify the data in various source systems; and track the data in spreadsheets (35% of respondents) or homegrown systems (25% of respondents). Prior to releasing funds to the sites, the Clin Ops teams must pass the findings to the financial team or manually enter them in the financial system.
These manual entry, verification and tracking processes remain labor-intensive (a quarter of survey respondents reported they have 6-25 resources managing the day-to-day site payments process), result in poor resource utilization (Clinical Research Associates/Project Managers spend up to 40% of their time on payments), and add to the burden of end-of-study reconciliation (taking an average 3 months, but nearly 20% of survey respondents spend up to 6 months). These processes also create challenges with amendments, changes to the data, duplicate invoicing and data access by all team members.
Sponsor-Reported Challenges with Site Payments
It's no wonder then that a lack of real-time visibility into payments (44%) and cash flow management (43%) were the most commonly reported challenges sponsors face with site payments in the FierceBiotech survey. The "blackbox" of site payments – 47% of the sponsors do not know how much they overspend due to payment errors and inefficiencies – also speaks to the lack of transparency and control that sponsors are experiencing. With 10s of millions of dollars moving through the different parts of the system, weak reporting and controls should be a concern.
Desired Characteristics of a Site Payment System
When you flip the question around and ask sponsors what they want from their site payment method, it makes sense that they respond with transparency of the payment process and control over their cash flow. Payment accuracy, payment timeliness and reporting capabilities were also considered important characteristics to determine whether sponsors are satisfied with their current site payment system. For reporting capabilities, they need to span the entire trial lifecycle – providing the information needed to show compliance with the Sunshine Act, financial reporting and other audits.
Sites are often dissatisfied with a lack of transparency into their payments – late and inaccurate payments challenge their own cash flow management. As a result, sites are becoming choosier in terms of which sponsors they are willing to work with – looking for a "sponsor of choice" that can deliver payments for work completed and showing that the site payment process can be a differentiator in the increasingly competitive market for qualified sites.
More innovative and automated payment methods are crucial for achieving transparency and control. Purpose-built site payment technology can be leveraged for better payment accuracy and real-time data about payment status. Often, these technologies can integrate data from other systems (e.g., EDC, ERP, IVR, CTMS) for direct transfer of completed tasks that can automatically trigger site payment based on the contract terms (completion of subject procedures and visits). We all know that studies change, which can pose a significant burden to manage in manual systems; instead, site payment technologies facilitate change management for contract and protocol amendments. Additional benefits include just-in-time funding, automated accruals and invoice management.
Sponsors who move to this type of system benefit from better payment accuracy, fewer payment errors, less time reconciling payments, real-time data about payment status and cash management fostered by just-in-time funding, eliminating large amounts of money in escrow. When taken a step further, the real-time data can be used to re-forecast the study budget based on actual study status.
Automated payment technologies are not new – given the recognized benefits, why isn't more of the industry using them? We wanted to know the same thing, so we asked the question in the FierceBiotech survey. What sponsors responded was that they had a lack of knowledge about automated technology capabilities and that the lack of studies did not justify the cost.
I think it's important to find a partner that is open to collaboration and can tailor the implementation to the specific needs of each sponsor – small to large. Education about what is possible within the current construct is important to help determine the scale of initial investment required to start realizing the benefits of automation. Even small steps away from the existing manual, error-prone methods can help make the site payment process more efficient and effective, shifting valuable resources from finance-related administrative tasks to study planning and execution.
Bioclinica's Site Payments Business Process Outsourcing (BPO) service provides complete study onboarding, management and maintenance of investigator site payment services, enabled through our Site & Patient Payments technology. Email me to learn more about our Site Payments offerings.