By: Sharon McFadden, DVM (Vice President, Clinical Operations & Medical Affairs)

 Figuring out a proposed budget for clinical sites can be challenging: knowing how to construct and execute the financials are a pivotal piece of trial design.

Here are some suggestions to aid you in your budget design:

1. As a starting point, create a list of each protocol specific line item and assign a proposed dollar value. These values may be derived from previous budgets or input from a friendly clinical site who can share typical costs. Complex costing tools are also available but can be quite expensive to access.

2. Estimate the time for the research coordinator and/or Investigator for each task.

3. If any parts of your line items are Standard of Care for a site, you do not need to reimburse for those, as the patient’s insurance will cover it.

4. For your medical device covered under an IDE, don’t forget to apply for Medicare coverage with CMS.

 

These are just the starting points!

If you need help creating and/or negotiating study budgets, contact Global RWC for assistance from our highly knowledgeable Clinical and Medical Affairs team. Email us at research@globalrwc.com or visit our website globalrwc.com.