Clinical trials do not exist to track budgets and payments; yet no clinical trial can commence or succeed without accurate, transparent financial management.
Like tracking clinical trial research data, tracking financial information requires a consistent system that balances usability and security. With digital solutions like Anju’s CTMS Master, clinical trial teams can define site budgets, track payments and invoices, and manage financial obligations with better transparency, accuracy, and security.
Financial Management: A Challenge for Every Clinical Trial
Clinical trials rely on their budgets to provide the resources they need to perform necessary research. However, clinical trial budgets have been increasing in recent years — often without a clear corresponding increase in the value of the information obtained in those trials, write Hemme J. Hijma and fellow authors in Nature.
Budget items that clinical trial sites must manage include:
- Investigator fees for investigators’ time and expertise.
- Salaries for study coordinators and other staff members.
- Laboratory testing, imaging, data management, and other ancillary services.
- Study advertising, pre-screening, enrollment, and other patient recruitment tasks.
- Lease, rental, or purchase of facilities and equipment.
Clinical trials can also face a number of financial risks, writes Wendy Schroeder at NAMSA. Fraud and abuse risks arise in billing patients or insurance carriers for research costs if those costs are covered or paid for by another source. Projects funded in excess of fair market value may violate anti-kickback laws. Finally, a non-profit site that takes on a project resulting in a financial loss might be seen as subsidizing a for-profit entity.
Creating a transparent, detailed, accurate budget that meets regulatory requirements is a must, but clinical trial teams don’t always have the support in financial management that they have in other areas of a study. Sponsors have detailed timelines in mind, but rarely want to expend the same effort on detailed budgeting, preferring instead to leave that work to CROs or clinical trial sites. Implementing best practices with cutting-edge digital solutions can provide the necessary support.
Best Practices for Financial Management in Clinical Trials
Financial management in the clinical trial context includes budgeting, payments, and other tasks.
When creating a clinical trial budget, the University of California San Francisco’s Clinical Research Resource HUB recommends that clinical trial teams consider the following three components:
- Identify costs for all research items and services required by the study. Closely monitoring fair market value in this process can keep clinical trials compliant with anti-kickback laws.
- Assign financial responsibility for each research item or service. Who will pay for it, and how will the money be allocated and distributed?
- Create a cost recovery process and implement it consistently throughout the study. Create schedules or timelines as needed and use a single digital or other source for information and cost recovery practices.
Best practices for financial management in general also apply in clinical trials. These include:
- Understanding the financial impact of a project’s objectives. What do the planned outcomes translate to in terms of dollars?
- Creating an adaptive system for budget forecasting.
- Identifying who needs to participate in the project for it to succeed — and the associated costs of their participation.
- Mitigating risk and addressing regulatory requirements consistently.
- Using technological tools for forecasting and modeling to make better decisions based on available data.
Finally, streamlining budgeting and payment efforts can help manage costs and provide better insights. Archetype Consulting estimates that financial analysts spend nearly half their time collecting data and only 23 percent of their time doing the analysis that provides essential value. Using a digital solution custom-tailored for clinical trial budgeting can reduce the time spent collecting data and increase the value of time spent on analysis and essential tasks.
Clinical Trial Budgeting and Payments Solutions
Anju’s CTMS Master is designed specifically to support trial sponsor and CRO efforts to manage clinical trials without facing technical challenges. CTMS Master offers robust capabilities in study finance management, including:
- Budget template tools. Define site-specific budgets from a default template within CTMS Master and access information essential for budget forecasting and adjustment, like key documents and project insight metrics. Create multiple budgets and budget versions per clinical trial site.
- Payment tracking. Track both accrued payments and future obligations within CTMS Master, accessing related budget and forecasting information when needed. Define whether each payment type is automatic or must be manually approved and by whom. Use role-based access to ensure that only those authorized to handle payments have access to payment information. Make event and visit payments and track payment holdback, tax, and overhead percentages.
- Invoicing. Produce invoices on behalf of investigators and other vendors. Track invoices automatically and use a streamlined format that is consistent with applicable branding. Use standard or custom conditions to approve transactions and invoice generation.
CTMS Master also offers eTMF functionality, allowing for focused study of clinical trial information and its connection to budgets. Study teams can even set currencies for projects and budgets, facilitating clinical trial efforts in locales throughout the globe.
With these tools, CTMS Master supports best practices in financial management of clinical trials. Trial teams can forge ahead, confident they have the resources necessary to meet essential goals.
Images used under license by Shutterstock.com.
Authored by Laura Acosta, VP of Product Management, eClinical Division
Laura Acosta, VP of Product Management for Anju’s eClinical Division, brings over 25 years of experience in life sciences software, including significant roles at Oracle Health Sciences. With academic credentials from Boston University and Tufts University in Computer Science, Laura excels in navigating the complexities of eClinical solutions. Her commitment to continuous learning and innovation has earned her recognition as a trusted leader in the field. Connect with Laura on LinkedIn to explore her expertise further.