As clinical trials are becoming more complex, so are protocol budgets. A comprehensive, detailed budget is essential to the financial health of research sites. However, the budgeted amount provided by the sponsor or CRO often does not reflect the actual costs involved to carry out the research at sites. It is then that sites must assess their needs and put on their negotiating hats. Here are three tips for effective negotiation.
Tip #1: Know your situation
It is important to know where you stand with the sponsor as well as with your own capabilities as a site. Have you worked with the sponsor before? How did it go? Sponsors are likely to seek out sites they’ve successfully worked with in the past. If sites have had high enrollment numbers or have the capabilities to handle difficult indications, they will earn higher leveraging power with the sponsor.
Tip #2: Ask the sponsor for trial history
Learn as much as you can about the history of the trial. How long have they been recruiting and how many patients have been recruited thus far? Studies that have had a slow start or show signs of struggle will likely be easier to work toward a higher budget, if you are able to meet the protocol requirements. If you are able to bring in high enrollment numbers for the protocol, your site will be in a much better position to negotiate.
Tip #3: Go high on the first offer
This may sound obvious if you’ve ever negotiated before, but it’s important to not be afraid of going high. Remember that there may be a bit of back and forth before an agreement is reached, so starting high on the first round will allow for more flexibility. Because the sponsors want to work with you, they’re not likely to turn you away just because of a high request. Aiming high allows for you to meet in the middle and, if done correctly, will permit you to fully carry out the trial while still making a profit.
When calculating your budget, it is also extremely helpful to know the time it takes staff to complete various study-related activities. By understanding the true cost of conducting trials, sites can present a truly thorough budget to the sponsor or CRO, and thus, increase their likelihood of being adequately compensated for the protocol.