Even though sponsors mainly benefit indirectly when dealing with research sites equipped with more efficient data preparation tools and procedures, they can also benefit directly in several ways. While the details of site technology are not mentioned in a budget negotiation with a sponsor, there are benefits to sponsors which could be transparently included in fee schedules and justification letters.
Many sites have successfully received reimbursement for the increased effort when the industry transitioned to remoted risk-based monitoring, so you may also be able to negotiate for reimbursement of some technology related expenses or imbed them in fees.
Decide what kind of negotiation is comfortable for your organization. Negotiations based on trust that build a mutually beneficial partnership are longer lasting. Evaluate each case, staying open to creativity.
The ideal approach is to do your homework regarding your organization’s actual capabilities, calculate related fixed and variable expenses, and include them in your fee schedule up front with simple descriptions (avoid being too detailed in the fee schedule). In the context of a clinical study, fixed costs are typically associated with costs per unit or activity related to tasks. In contrast, variable costs relate to time and effort or business costs such as overhead.
By working-in some remote monitoring data preparation and access technologies, including any related personnel expenses into your initial fee schedule, you don’t have to over-emphasize the technology, since it is expressed in terms of services and fees within the correct context. By keeping the initial descriptions brief, you leave room for more details to be introduced as needed during collaborative talks.
One of the fees you can feel secure including is the remote monitoring fee. This has become common practice for many sites, with most sponsors now accepting it as standard. Be sure to work this into your fee schedule.
The same software that provides the remote access for the monitor is also the software that helps increase the quality and speed of study data delivery while maintaining compliance.
If further negotiation is needed on the initial fee schedule, this is where the “Cost Justification Letter” with more details can come in. In fact, it is often best to have one ready just in case, allowing for a mutually beneficial response time. This is also where including more capability statements and technical details may be useful, though still requires a certain degree of creativity and writing talent to get the language right for each opportunity.
The Site Cost Justification Letter
Below are some tips that might help you formulate a Site Cost Justification Letter that could increase the chances of having most, if not all the remote monitoring costs reimbursed. However, before you can write a justification letter, you need to reference the items calculated for the fee schedule, paying special attention to ones that need further justification. To be clear, the “Site Cost Justification Letter” should still list all of the fees, with a more detailed “justification” letter for each, with special attention to the pushback items. This type of letter enhances transparency and helps standardize the expectations of both parties on the same page. Once you have developed a true understanding of your internal costs, you can offer highly transparent numbers that go across your direct and indirect costs generated by regulatory and administrative efforts across your portfolio. By adding more detail and explanations for each fixed and variable cost captured earlier, you can provide details covering resources, overhead, supplies, and technology tools used in support of remote monitoring.
Summing up, the basic strategy is to build the costs into the CTA (Fee Schedule), providing a justification for each that also explains why the costs are higher. A site benefits even more by investing in the right eClinical tools that update data with their CTMS workflow (CC CTMS), which can lead to more reimbursements by the sponsor if the expenses are well justified. CCeSource, CCeConsent and CCeReg are particularly beneficial, since they provide the bulk of the visit completion, electronic consenting, and regulatory remote monitoring capability. Besides gaining points with Sponsors for helping them save an average of 40-50% of the cost of a study by providing remote monitoring access, sites also gain efficiency and strengthen their organization with workflows that help ensure safety, save time, reduce effort, increase organization, help maintain compliance, decrease expenditures and provide the flexibility to collect data or ensure oversight from any location.
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