A critical need for timely site payments
Research sites across the globe likely have felt the effects of delayed payments, inconsistent payment amounts and lack of explanation regarding what the payment was for. In a 2016 survey of Investigators conducted by DrugDev, getting paid “on time” was one of the top two burdens reported by sites. Receiving untimely payments not only produces financial stress to the site, it often leads to additional administrative load placed on staff members who must allocate resources to track down payments and deal with discrepancies.
Increased study costs due to protocol complexity make the issue of receiving timely payments more critical than ever. According to a 2016 SCRS Site Payment White Paper, 66% of sites work with less than three months operating cash, often leading to higher investigator turnover. When sites are expected to cover more costs up front, site staff have no choice but to prioritize billing issues in order to stay afloat. The time and energy spent on managing payables typically creates a cascading effect, resulting in less time spent with patients or on clinical conduct, late patient stipends and even tax implications. All of these deferrals eventually result in delayed clinical trials and ultimately, cost the sponsor more money.
Sponsors and CROs recognize the importance of treating research sites as valued business partners, and many are implementing solutions to streamline the payment process in order to allow site staff to focus resources where they are needed most—on conducting clinical trials. Technology and automation play an integral role in these efforts as many look to streamline complex processes.
As Electronic Data Capture (EDC) is now commonly used, these systems provide a platform that allows for real-time communication with accounts payable systems. The ability to trigger payments tied to the completion of study milestones helps accelerate the flow of cash to the site as the need for additional paperwork and invoicing is eliminated. Additionally, when these systems are put in place, the payment trigger is tied to the action of a site inputting the EDC data. This gives the site more control over when payments are received, as well as provides an incentive for study staff to input data in a timely fashion.
In addition to automating payments, sites can request CROs and sponsors provide more transparency and access to financial information from the beginning of a study-related relationship. Early access to financial information will also provide sites with a solid understanding of the study and will help to ascertain feasibility. This can equate to a more reliable commitment overall to study performance as a whole.
Another element to consider are types of payments that are not necessarily triggered through an EDC system. IRB fees, recruitment or advertising spend, storage fees (to name a few) and other types of costs can occur before the study even begins. It is critical to take all of these factors into account and for sites to request start-up payment that is adequate to cover these costs. Fortunately, as sponsors and CROs better understand the need to ensure sites value start-up reimbursement, these average start-up payments have steadily increased (See Figure 1).
The Clinical Trial Agreement (CTA), provides several opportunities to help streamline the payment process as well, for example, establishing 30-day payment terms. Sites are most familiar with quarterly payments, or even longer, leading to unfavorable financial conditions for sites. More frequent payment terms will contribute toward keeping the site financially solvent, and ultimately, more sustainable. A possible contract term to consider adding to the CTA is to require all necessary back-up information with payment—protocol number, subject initials, visit date and a list of all procedures performed—as often, payments are not easily tied to a specific study. In most cases, when payments are automated, this is a simple process that can save site personnel hours of time. Most technology-based payment platforms support this feature and cause little additional work, if any, to the sponsor or CRO—but can save hours for sites.
Sponsors, CROs and investigators each have important roles to play in terms of bringing new medicines to market. The role of the investigator and research site is best suited to be focused on patient-facing work. Sponsors and CROs typically have the infrastructure to support automated and more frequent payments terms, and are in a good position to help relieve administrative burden placed on sites. Research sites can help facilitate these terms by engaging early and often with the sponsor or CRO prior to accepting a new clinical trial.
Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Synexus is proud to be the patient’s choice for clinical research. Email comments and questions to firstname.lastname@example.org.
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