For those who have spent any amount of time in the clinical research space, there has always been an apparent and unspoken priority to the different operational components of trial execution. Certainly the priority made sense, for the most part, but at some point everything catches up to you. If you had to rank the priority order of some of the core clinical trial execution components, it would probably go something like this:
- Protocol Design
- Site Identification and Selection
- Investigator Meeting and Training
- Required Services: CROs, Vendors, Labs
2. Data Management
- EDC, eSource
- Data Management Specs
- Investigator and Site Discussions
- Site Selection and Qualification
4. Patient Recruitment Strategy
6. Study Startup – Contracts (CTAs) & RegDocs
7. Site Payments
The above priority spectrum was also evident with the development of the traditional CTMS systems, which focused on site identification lists, key milestones, monitoring reports, enrollment tracking and the like. If you looked hard enough in the systems you would eventually find some type of module to track your site CTA execution dates and maybe a module to make simple investigator payments – and hope you don’t have an amendment. Beyond CTMS, all types of system and technological developments have been seen in the last 15 years – from widespread adoption of EDC and now headway into eSource and wearables, to digital health, real-world evidence (RWE), risk-based monitoring, and patient-engagement.
While there are many areas of the clinical trial lifecycle that garner attention, and are certainly buzz-worthy, there are still a few impactful components of the process that have failed to adequately make the radar and resonate with all sponsors and CROs, large and small. Investigator site payments, while sites would agree are a major headache for them, still just have not received the focus and attention they deserve. The Society for Clinical Research Sites (SCRS) has even identified improvement of payments as an “Industry Imperative” in their 2012 paper “Better Payment Terms for Sites”, and recommends 30-day payment terms with sufficient payment remittance in their 2016 “Site Payment” paper.
“Legacy, outdated processes related to site payments place sites in an unfavorable financial position, adversely impacting site sustainability and the willingness of investigators to remain in clinical research” (SCRS Site Payment Paper 2016).
On one hand, small and mid-size companies generally assume the CROs they hire will handle payments because it is in their contract as part of managing the whole trial. On the other hand, the larger companies often have a hybrid outsource strategy which can yield inconsistent payment methods with the sites, as payments could be made by internal staff, outsourced 3rd parties, or CROs. Finally, the CROs themselves often assume they need to be the experts at all facets of trial execution. Consequently, they are hesitant to seek third party help and, often to the dismay of their sites, continue grinding through the payments on spreadsheets or homegrown tools.
The Impact of a Poor Site Payment Process from a Sponsor/CRO Perspective
First, site payments should not be treated as just an administrative, back-office process. Underestimating the complexities of the process is one of the primary downfalls of many clinical trial programs when it comes to payments. Additionally, a sound payment process starts with the execution of a clinical trial agreement with terms that are clear and concise, that can be monetized into payment during the execution of the trial. If a CTA contains convoluted payment terms, neither the site nor the payment administrator will readily be able to calculate, issue, and reconcile the disbursements and ensure accurate payments. The first step for any size sponsor or CRO is recognition of the importance, opportunity cost, and potential negative impact on all the key stakeholders from their organization to the sites’.
The site identification and recruitment space is highly competitive. Sponsors and CROs can gain an edge when trying to court sites to participate in their trials – particularly when trying to identify high-performing research sites. Having a payment process that focuses on quick and accurate payments with high customer focus will portray you as a sponsor/CRO of choice. According to the 2016 SCRS Site Landscape Survey, sites operate on thin 13% margins and 66% of sites have less than three months of operating cash. As such, sites simply cannot afford to sustain themselves and take on studies that will result in poor cash flow. Moreover, continued poor payment practices will further deter much needed research naïve sites from joining and contributing to clinical trial programs and the development of new medicines.
Site Engagement and Patient Recruitment
Imagine you have two jobs to support your family. One job deposits your paychecks electronically on a monthly schedule – and provides you details about the work you completed with your disbursement. Your other job, which requires just as much effort, sends a check in the mail to you roughly every three months for an amount you hope is accurate because it lacks a detailed remittance advice. To which job do you think you will devote your time and energy? While the answer is fairly obvious, it is a question that is faced by many research sites on a routine basis when dealing with payment practices from their sponsors and CROs…As a sponsor or CRO, which “employer” do you want to be in this scenario?
In this example, the answer is simple but the reality is that many sponsors and CROs simply do not think about payments or enhancing them because there are so many moving parts in a trial that demand the team’s attention. Going back to the prioritization exercise above, payments in the clinical research space are not a typical accounts payable function, nor should they be treated as such. A clinical trial is comprised of many functions that can fall on the critical path. While payments will not necessarily delay the start of a trial (unless you have a site demanding better payment terms in their CTA), they can critically impact the outcome of your trial with disengaged sites and reduced enrollment potential.
Financial Controls and Reporting
Investigator Site Payments have many inherent complexities in their management that increase at a global level. Lack of sound payment processes frequently yield challenges in treasury management and financial reporting for clinical and finance teams alike, often due to decentralized processes that commonly are managed in desktop spreadsheets and databases. Moreover, reporting to meet US and growing global transparency requirements, as well as accrual and forecast management is often a significant challenge as well. Lastly, the fact that the investigator line item typically accounts for about 50% of a total trial budget also should raise eyebrows and investment in this area.
While we have seen increased awareness in recent years and solutions are now available, the adoption and implementation of these is still low. Market solutions range from technology-only platforms to full business process outsource (BPO) approaches. Regardless of the approach, it is essential that you have experts incorporated who understand the nuances of not only global payments, but also the pre-cursor to the process which is the clinical trial agreement. The clinical trial agreement is the basis by which payments are administered, and from structure and format to location of contracting parties, a well-prepared CTA and associated budget will set the payment flow for the study.
Irrespective of technology, issuing payments is still not just a push of a button; data integration, site support, quality control, study setup, reconciliation, and treasury are just a few of the considerations around a holistic solution. Surrounding any payment platform should be expert resources and processes that balance control with efficiency to successfully manage any size portfolio – from 1 study to 500. Sponsors and CROs need to think about and evaluate their core competencies, and decide what functions should be kept in house, and which ones should be outsourced. It ultimately comes down to a question of focus and the ability of study teams to give site payments the attention they deserve.