Negotiating a clinical trial budget isn’t rocket science, but it is most certainly an art form. You don’t need to be an expert, but you should absolutely be aware of all the different aspects of running and operating a clinical trial so that you are negotiating effectively and intelligently. Lori Rich, our Director of Finance, had some very interesting input as well!
- Understand the entire protocol front-to-back: You need to know what is expected of both the PI and the site staff at each patient visit throughout the duration of the trial. Are you outsourcing your patient scheduling and phone screening? Are you going to need advertising to beef up your database with qualified patients? How are you disposing of the drug at the end of the trial? “Footnotes are crucial to ensure that you are appropriately accounting for all assessments that are required to be completed,” says Lori. Knowing each expense ahead of time is necessary so you can make sure those costs are accounted for in the proposed budget. Being able to back up all requests with something concrete goes a long way.
- Be prepared for multiple conversations regarding the budget: In addition to knowing the protocol and how much compensation you need from the sponsor/CRO in order for the trial to be worth conducting, you should also be aware of budgets for similar indications. Do your homework. “Have documentation and rationale ready ahead of time for your requests,” says Lori. ”We see this often requested during negotiations – by having this ready ahead of time for things like startup, pharmacy fees, and study close out, you will be able to reduce the length of the negotiation, get more approvals, and alleviate stress when being asked for these things.” Lori also states, “You do not have to accept ‘no’ for an answer on items after your initial request. Often it may take two or three times asking before your request is escalated to management for approval.”
- Establish a relationship or candor with whoever you’re negotiating with: Of course you both have a job to do with opposing goals, but you can achieve these goals benevolently. You’ll be working with this person for the next couple of weeks at the least, and going over some pretty mundane aspects of the trial process. Let your personality blend into the relationship. Pick up the phone and show them who you really are and that there is a voice behind the email address. Building trust right off the bat will open up the communication pathways and allow for positivity and partnership, rather than one side versus the other. Not only should you understand your perspective and why you feel your budget should be accepted, but understand your counterpoint. Ask questions in order to gather as much information as possible. Being proactive by understanding why the sponsor/CRO is only willing to reimburse certain items at x amount of dollars gives you the opportunity to prepare a persuasive argument which will benefit your site, and your partners, in the long term!
To learn more about improving efficiencies when it comes to financial management for your site, listen to our webinar!
