The Role of Financial Management and GAAP in Clinical Research

Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more.

However, in order to maintain a successful research program and ensure long-term growth, a site also needs to focus on running their organization as a business. Visibility into and control of the financial aspects of a site’s research portfolio are key to building a successful financial site workflow.

In this article, we will explore the importance of sound financial practices for sites. We’ll also outline how utilizing a clinical trial management system (CTMS) that provides comprehensive financial management and adheres to Generally Accepted Accounting Principles (GAAP) can help ensure financial success.

Financial Management Focus Areas for Sites

1. Budgeting: Research sites need to create detailed budgets accounting for all study-related expenses to ensure they have enough funds to complete the study successfully. A CTMS can provide the necessary budget tracking and reporting to help ensure a site is negotiating using a solid foundation. Financial management tools can help research sites secure the maximum allowable compensation for their services, thereby increasing revenue.
2. Maximizing and recovering revenue: Similarly, it is important for the site’s financial team to make sure they are recovering all the revenue they are owed. Oftentimes, sites hold off billing for specific visits or procedures related to a trial if they are not 100% sure the item is billable. This fear of non-compliance can significantly affect a site’s bottom line. A CTMS can significantly improve a site’s billing process and visibility, uncovering disparities in allowed vs. billed items enabling the site to confidently bill the sponsor.
3. Allocating resources: Clinical research is resource-intensive, requiring funding for staff salaries, equipment, supplies, participant recruitment, and administrative overhead. Effective financial management tools help allocate resources efficiently, ensuring funds are available for essential aspects of research.
4. Reporting: Research sites, especially standalone sites, site networks, and health systems, often track financial items in silos. This makes it difficult to gain the visibility needed to make intelligent, data-driven decisions. Adopting a CTMS with comprehensive financial management capabilities ensures research sites are surfacing the proper data to make the right strategic business decisions.

The Role of GAAP in Financial Management

GAAP is a set of accounting principles, standards, and procedures designed to guide financial reporting and, where applicable, disclosure. There are ten total GAAP concepts financial professionals should adhere to, which provide several benefits to research sites:

1. Consistency: GAAP ensures consistency in financial reporting, making it easier to understand and compare financial statements. A consistent month-over-month and year-over-year financial picture can help leadership truly understand the financial state of the site.
2. Completeness: Compliance with GAAP standards ensures all aspects of a site’s financial performance are captured, providing a complete financial picture.
3. Timeliness: GAAP-compliant financial workflows ensure financial data and reports are as up-to-date as possible, promoting real-time visibility into the site’s financials.

The Role of CTMS Reporting in Financial Management

While a full-featured CTMS can address all of the topics mentioned above, reporting capabilities in particular can significantly improve financial management and visibility. Advarra’s Clinical Conductor CTMS provides comprehensive financial management tools, including:

• Balance sheet reporting to gain insight into study- or site-level balance sheet, with reporting detailing assets, liabilities, and equity
• Income statement reporting to easily show profit and loss data for any timeframe
• Revenue forecast reporting to project revenue based on visit windows, potential study enrollments, engagements, and more
• Aging reporting to track study invoice activity not yet been paid, with visibility across all studies

If your site, site network, or health system is looking to streamline financial management and improve your ability to run your research as a business, check out the Clinical Conductor CTMS. Our platform provides scalable financial management along with tools to help your site optimize research operations, stay compliant, recruit and enroll participants, and more.

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