Clinical Researcher—April 2022 (Volume 36, Issue 2)

ON THE JOB

Debbie Taylor, MBA

 

Once you’ve secured an industry-sponsored clinical trial for your site, how can you make sure that the study runs smoothly and you are capturing all the revenue that your site is due?

Documentation is key to keeping track of key dates and collecting all payments due. In order to know the financial status of your study, you need to see how those collections impact forecasted budgets in real time. Payment terms are often complex and protocols often change, leaving many sites with payment delays and unrecognized revenue. Tracking this information in an online database simplifies life for research coordinators, while allowing the finance team to see the “big picture” status of your site’s trials.

Here are nine tips to help keep your financials on the straight and narrow from study start-up to closeout:

1. Budgets: Create an internal budget to link revenue and costs to the appropriate timelines. Include all expected payments from the coverage analysis (CA) billing grid into your budget as well as administrative costs (e.g., study start-up and institutional review board [IRB] fees). Rather than simply using an Excel spreadsheet, it is preferable for principal investigators (PIs) to upload the CA to a database to create an internal budget.
2. Dates: Make sure payment terms and specified payment triggers and timelines (e.g., IRB deadlines, goal dates, and signatory schedules) are integrated into calendars and reminders to ensure the study stays on track.
3. Enrollment: Keeping track of metrics on enrollments is key to making sure your site is meeting specified targets. Make it easy to ensure that payments triggered by reaching certain enrollment targets are collected. Keep enrollment and payment data and key dates in one integrated system that automates calendar reminders.
4. Finance: Make sure that accounting keeps invoices organized to avoid billing errors and misallocating payments. Manually scanning copies of invoices and checks and storing them in computer folders with naming conventions is a cumbersome and error-prone process. It’s even more difficult to do when sites, running different trials for the same sponsor or contract research organization (CRO), get a lump sum payment. Invoicing integrated with accounting systems like QuickBooks can be a game changer.
5. Monitoring Visits: Payment terms that rely on data monitoring often cause significant payment delays. Keeping tabs on key data monitoring dates is easier when those dates are visible in the same place as payment data. A database with automated workflows can populate calendars and send reminders.
6. Holdbacks: After all their hard work, sites often neglect to collect holdback payments and closeout costs once a study is complete. Carefully track and manage accounting of holdbacks to make sure that all revenue that your site earned gets collected. This can require follow up for months or even years after a study ends.
7. Completed Line Items: Payments terms are complicated and depend on scheduled dates and key targets. It is hard for PIs to wrap their heads around what receivables might still be outstanding. See all the completed line items in one place so you can narrow down what payments may need to be followed up on.
8. Forecasts: Accounting entries made in siloed invoicing spreadsheets will not be reflected in real-time status of actual budget numbers vs. forecasts. Having an integrated system that automatically updates forecasts when payments are made or delayed allows the finance team to see the status of your study in real time.
9. Metrics: A system that tracks all of your studies has the added benefit of automatically providing marketing metrics on your site’s overall success across all of your trials. Know how long your site takes to enroll the first patient, execute a contract or budget, and whether you meet sponsor/CRO timelines. Having these metrics readily available is key to standing out among other research sites and getting selected for the next study.

Conclusion

Don’t reinvent the wheel trying to manage complex studies. Technology can ease the burden. Systems built in collaboration with industry experts often better fit sites’ needs than a huge, expensive clinical trial management system.

Debbie Taylor, MBA, is CEO and Founder of CloudBase Services in Berkeley, Calif., a management consulting firm that designs systems for clinical trial study sites, including the Haspoa Horizon application for financial operations. She has also worked at Kaiser Permanente and Apple. Debbie holds a bachelor’s degree from Princeton University and an MBA from Stanford University.