Biopharma trial expenses: From spreadsheet to solution platform

An efficiently run clinical trial is the foundation for any growing biopharma company. From setting up protocols and testing methodology to identifying test subjects and data analysis, there’s much for an organization to track, assess and report on. And, to add to the clinical trial complexity, organizations must also be diligent with their accounting efforts and cost management during the various trial phases.

“Clinical trial expense management, in particular, can be a manual, complex, Excel-based process often burdensome for biopharmas focused more on science, innovation and development,” said Justin Culbertson, senior analyst for the life sciences industry practice at RSM US LLP. “Inaccurate and delayed reporting can impact accounting, finance and clinical operations. For public biopharmas, or those looking to go public, these challenges significantly increase audit risk, too,” he said. While optimal expense management may be one of the areas that is neglected during clinical trials, Culbertson emphasized it could be a game changer for many growing biopharmas.

“A specialized solution, underpinned by technology and geared precisely to the challenges of clinical trial expense management, is the key to improvement,” said Culbertson.

“A technology solution can consolidate financial and clinical data to streamline financial close and mitigate audit risk,” Culbertson said. “It can also allow you to own your numbers without excess reliance on contract research organizations and other third-party vendors, and removes the need for spreadsheets too. And, very key to the organization, it can realign clinical operations and finance so areas are integrated rather than working in silos.”

Key questions to consider

How do you know your organization needs to upgrade from spreadsheets to a best-in-class, technology-enabled solution? Culbertson indicates the following questions might provide some insight into your next steps:

1. Do you lack the time to gain the critical insights into your clinical trial expenses that you know are possible in an ideal state?
2. Are you continually addressing errors in your expense tracking and experiencing delays in reporting?
3. Have you been caught off guard by unexpected change orders?
4. Are you over-reliant on your vendors to provide you with your numbers?
5. Does your current expense process lack flexibility or the ability to grow as your trial scope changes?
6. Do you lack confidence in your data and are you concerned about audit risk?

Culbertson said answering yes to any of the above questions might signal a change is needed. A technology-enabled solution could mean the following benefits:

• Reduced time to close your books.
• Enhanced and flexible data modeling that can help anticipate study overages.
• Improved forecasting, estimating and scoping.
• Improved integration between clinical and finance to collaborate on clinical trial status.
• Enhanced workflow functionality that enables process improvement and provides teams with a more streamlined way of managing responsibilities.
• Decreased audit risk due to improved tracing, audit-ready information and automated calculations.

The takeaway

Your biopharma is embarking on a vital phase of your organization’s growth journey. Just like the focus on innovation and testing is essential, equally important is the ability to track, report, assess and forecast expenses. While a spreadsheet might have been sufficient to track those expenses in the early days of your startup, complexity, integration, sophistication and accuracy are now driving your needs, and a smart solution, one that is enabled by technology and can grow with your organization, may be the answer for your future.