Negotiating a study budget can feel intimidating. You need to make sure your costs are being covered but you may feel overwhelmed and intimidated by the process of communicating your site’s needs. Negotiating is not scary or overwhelming when you understand your costs and are able to communicate your reasoning.
The first step in negotiating your study budget is to thoroughly understand all the requirements and costs of the study. In addition to the protocol, request the central lab manual, a copy of the eCRF, the pharmacy manual, and any other documents associated with the study. Use this information to build up your own budget worksheet and checklist. While the protocol procedures may make up the bulk of the study costs, also ensure the costs of all the administrative tasks are covered. It’s easy to forget how much time is spent on study start-up, monitoring visits, and answering queries. This time needs to be covered within the budget.
Now that you truly understand your costs, you can confidently request what you need and the negotiation process begins. There is no need to feel intimidated when submitting your edits to the Sponsor template. Remember, all sites negotiate their budgets - it’s just a part of the job so it’s not personal or stressful.
Your revisions to the Sponsor template should be logical and matter-of-fact and when you receive the Sponsor’s feedback on your edits, keep communicating. Sometimes when there are discrepancies between your numbers and the Sponsor’s, you’ll realize a specific procedure won’t be as time consuming as you initially thought or that the cost to complete will be less. Collaborating, keeping communication open and respectful, and logically working through your study costs, are the steps to a working budget.
Although some budgets may need to be rejected since the site and Sponsor’s budget cannot meet, it’s best to have this hard look at the numbers now before the contract is signed and you’re committed to the study. You can confidently make the decisions necessary to accept the budget or pass since you understand your costs thoroughly and have communicated your needs.
Engaging a service provider such as Primesite to help work through budgets and help negotiate can also help relieve a lot of stress. We can help busy sites work through their study budgets methodically so nothing is missed. Contact us to learn more.