For successful negotiations, sites must consider the full spectrum of benefits they bring to a sponsor. This often means thinking of site tools that haven’t historically been included in negotiation discussions, including technology capabilities. While the details of site technology are not mentioned directly in a negotiation with a sponsor, there are direct benefits to sponsors which could be creatively included in fee schedules and justification letters. For example, many sites have successfully received reimbursement for their transition to remote risk-based monitoring. This is because the same software that provides the remote access for the monitor is also the software that helps increase the quality and speed of delivery of the study data while maintaining compliance; making this connection clear to a sponsor will go far in negotiations.
How to Include Costs in Your Proposal
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. 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 including remote monitoring data preparation and access technologies into an initial fee schedule, sites don’t have to over-emphasize the technology since it is expressed in terms of services and fees within the correct context. In addition, by keeping the initial descriptions brief, you leave room for more details if there is any pushback.
Fixed and Variable Cost Justification
For fixed costs, be sure to include a short description of each role related to the monitoring tasks, since each task can be unique depending on who is performing it. This changes the FTE calculation. Also be sure to break down the difference in cost from traditional, onsite monitoring and remote monitoring. Even with your personnel, technology and other fees included, the electronic preparation of data and remote monitoring will cost much less for the sponsor than having to perform onsite visits. Some monitoring related items that may contribute to fixed fees include:
- Site engagement visits with monitor pre, intra and post award
- Review of regulatory documents related to clinical trial conduct
- Document management (scanning, copying, faxing, de-identifying)
- Duplicate document submissions for review
- Ongoing document reviews (continuing reviews, amendments, and annual reviews)
- Safety report reviews and associated documents (SAE/AE/DSMB reports)
- Remote Monitoring access fee (could be “fixed” if pre-calculated in tiers)
The same holds true for variable costs; be sure to compare the more efficient electronic data preparation and remote monitoring costs (time & technology) to the usually much higher cost of any non-electronic and manual approaches that would result from the sponsor not accepting the proposed fee schedule. Several monitoring items fall under a “variable fee”. Below are some items related to monitoring that you can list in your “variable fee” justification items:
- Time and effort for all research staff (training, education, webinars)
- Ongoing communication efforts
- Allocated meeting times dedicated to monitor during external reviews
It’s also smart to have a site cost justification letter ready to quickly respond if there is sponsor pushback. This letter should include more capability statements and technical details delivered in a strategic way that aligns your offering to what sponsors value. By adding more detail and explanations to each fixed and variable cost you’ve already outlined, you can provide details covering resources, overhead, supplies, and technology tools used in support of remote monitoring in your justification letter.
Negotiating with clinical trial sponsors is a necessary skill for any successful site team. Understand the value you bring to each trial and how to convince sponsors to pay for that value.