Knowing the true costs of a clinical trial – and being able to negotiate effectively with sponsors to ensure those costs will be recovered – are of paramount importance in a successful research program. Every activity associated with a clinical trial has a cost, and many different kinds of costs must be considered during the budgeting process.
Broadly, some of these costs might include:
- Personnel time including time for administrative work associated with the trial
- Travel
- Training
- Fees – hospital, clinic, laboratory, pharmacy, IRB review, etc.
- Advertising/recruitment
- Participant payments and reimbursements
- Supplies
- Storage
- Overhead
The increasing emphasis on research billing compliance further illustrates the need for a sound budgeting process. Inappropriate billing (billing the wrong party, or generating a bill for a non-billable service) and “double dipping” (billing more than one party for the same activity or item) must both be avoided. The consequences of noncompliance can be severe, particularly if Medicare patients are involved.
InfoEd’s Clinical Trials module features a complete Financials subsystem, based around a Procedure Matrix that allows every activity associated with a protocol to be tracked. Multiple project periods can be established to allow forecasting over the entire life cycle of the trial. Various cost recovery methods, payment schedules, and communications are supported within the module so that documentation is maintained. Research billing compliance is enhanced by the ability to clearly delineate financial responsibility for each trial activity, and through improved coordination between clinical and billing offices.
To learn more about InfoEd’s Clinical Trials module, contact Becca DuBose, Product Manager, at bdubose@infoed.org.
