Chris Monaghan, Associate Director of Site and Strategy at ClinX was recently on a panel at the SCRS conference centered around budget and contract negotiation for sites. Chris is an expert in the industry and has been working in the finance industry for almost a decade. Learn tips and tricks from an industry expert.
Q&A on contract negotiation for Sites
What do you look at when considering a clinical trial budget?
A: When reviewing a sponsor protocol and budget, I always like to check for the number of possible vendors involved at both the sponsor and site level as well as labs and screen fail ratios. It is important to have pricing set in stone with vendors prior to negotiations in order to make sure you are covering your site’s costs. Labs and screen failures go hand in hand, as one can dictate the other. I recommend always reaching out to your study contact to see what the projected screen fail ratio is for the entire trial; this gives you some prospective as to what to expect from an operations level as well as rationale for your initial request.
Q: Should you take on a trial if the per patient budget is low?
I always check to see who the sponsor is, prior to making any decisions. I would ask if you’ve worked with them before or is this a new relationship? Check with your team to see if this new project fits with your site and a good use of your time. Sometimes allocating too much time to a low paying study hinders your success on other trials. On the flipside, if your site is closing a few studies, this might be a good filler to keep your site busy while waiting for your next trial opportunity. Timing is always key!
Q: How do you justify overhead?
Overhead is very fluid across all sites as there are many underlying factors. How big is your site? Are you paying a lot for rent? Where is your site located? It is important to identify your site’s true overhead and be consistent with your request across all trials. At the end of each year, have a team meeting and go over the finances. Make sure your overhead is still relative and be sure to adjust accordingly.
Q: What do you look for when determining a screen fail ratio? How can a site alleviate their concerns if the Sponsor/CRO is not budging on their ratio?
As a rule of thumb, I always ask for all screen failures to be reimbursed. When determining a ratio, I look at factors such as indication, labs and diaries. The most common reasons for screen failures, in my experience, tend to be labs and diaries. I try to include language that allows for all screen failures to be reimbursed if they fail as a result of labs and diaries because the site cannot plan for these occurrences. If I need to have a ratio, I start with 5:1 (5 SF to every 1 randomized) and try to settle on 3:1. Every site should be asking for chart review and pre-screening log reimbursement as this will alleviate screen failures while also reimbursing the site for their time and effort. Lastly, during enrollment, constantly check your ratios and renegotiate whenever possible. Once enrollment closes, your leverage to negotiate is significantly reduced.
Q: What are your preferred payment terms and how do you justify this?
My terms have always been the same throughout my time in research. I ask for monthly payments with no holdback on every trial. Monthly payments ensure consistent cashflow at the site level and holdback have become a thing of the past, especially with more Sponsors/CROs going to electronic source. My justification to the Sponsor or CRO is simple, our site did the work and needs to be paid timely as they have other expenses to pay throughout the month. I will take bi-monthly payments if necessary, however, I make it clear that this is a concession on this trial and not our site’s long-term expectations.
If you have questions or would like a personal follow up with Chris, please email him at chris@btcsites.com
