Clinical trial accounting: Overcoming common challenges in life sciences

Clinical trials drive innovation in the life sciences industry. They enable the development of new therapies, medical devices, and diagnostics that improve patient outcomes and advance global health. However, behind every successful trial lies a complex financial and operational framework. Effective clinical trial accounting ensures accuracy, compliance, and strategic alignment across all trial activities.

For finance teams in the life sciences sector, clinical trial accounting presents unique challenges. These include tracking spend across multiple sites, managing accruals, and maintaining compliance with evolving regulatory requirements. The process is rarely straightforward. Fortunately, modern enterprise resource planning (ERP) software can help organizations overcome these obstacles. They streamline operations, provide real-time visibility, and reduce risk, making clinical trial accounting more efficient and reliable.

Clinical trials are multi-phase, multi-year projects. They involve many stakeholders, including researchers, sponsors, contract research organizations (CROs), vendors, and regulators. Financial management is complicated by several factors:

• Unpredictable costs: Protocol changes, patient recruitment variability, and site-specific expenses make trial costs difficult to forecast.
• Accruals and forecasting: These activities span fiscal periods and require precise estimation for accurate reporting.
• Third-party relationships: CROs, contract manufacturing organizations (CMOs), and other vendors generate large volumes of financial data across geographies and currencies.
• Compliance: Life sciences is one of the most regulated industries, requiring adherence to the Sunshine Act, FDA guidelines, GxP, and international data privacy laws in regulated environments.

Without the right systems, finance teams often rely on spreadsheets and manual, complex processes. Consequently, the risk of errors, delays, and non-compliance increases. Reliable data is critical for financial reporting and operational decision-making. Ultimately, maintaining data integrity is essential to ensure product quality and regulatory compliance.

Clinical research organizations often run clinical trials concurrently at multiple locations, each with its own budget, vendors, and timelines. Consolidating spend data and ensuring data accuracy is challenging, especially when systems are siloed or outdated. Effective project management is essential for coordinating activities and ensuring alignment.

Accurate accruals are essential for financial reporting and investor transparency. Finance teams must estimate costs for ongoing activities, reconcile invoices, and adjust forecasts as trials progress. Inaccurate accruals can lead to compliance risks and misinformed decisions, making accurate data critical.

Life sciences companies must comply with a range of industry regulations governing clinical trial spend. For example, the Sunshine Act mandates reporting of payments to healthcare providers. Failure to comply can result in fines, reputational damage, and delays in product approval.

CROs, CMOs, and other partners generate large volumes of financial data that must be integrated into the company’s accounting system. Manual data entry increases the risk of errors and delays, while a lack of integration hinders visibility and control. In contrast, automating routine tasks such as data entry can reduce errors and improve efficiency across departments. Integration of inventory data and operational data also improves overall efficiency. ERP systems connect these business functions, enabling real-time data sharing and comprehensive insights for better decision-making.

Rand Group helps life sciences organizations overcome these challenges by implementing life sciences ERP systems. These solutions integrate finance, supply chain management, quality control, and compliance into a single system. Our expertise covers three leading platforms: Oracle NetSuite, Microsoft Dynamics 365 Business Central, and Dynamics 365 Finance & Operations. Each platform offers advantages depending on a company’s size, complexity, and growth stage.

• Oracle NetSuite: Supports growing life sciences companies with cloud-based project tracking, automation, and compliance features.
• Dynamics 365 Business Central: Ideal for mid sized organizations, offering integrated financial and operational workflows.
• Dynamics 365 Finance & Operations: Serves enterprise-level organizations with multi-entity trials, advanced inventory controls, and global compliance capabilities.

With the right ERP platform, companies can enhance efficiency, visibility, and compliance, making clinical trial accounting more manageable.

Every life sciences company is different. Size, complexity, growth trajectory, and regulatory exposure all factor into choosing the best solution. Rand Group helps clients evaluate and select the life sciences ERP solution that best fits their needs. Moreover, during the evaluation process, we highlight how ERP systems facilitate compliance with industry regulations, helping organizations meet strict standards efficiently. Our process includes:

• Analysis of core business processes to streamline workflows and align ERP capabilities with core business requirements
• Requirements mapping to ensure operational needs are met
• Vendor comparison across NetSuite, Business Central, and Finance & Operations
• Implementation roadmap to ensure smooth adoption and long-term success

Whether you are a biotech startup preparing for your first trial, or a global pharmaceutical company managing dozens of concurrent studies, Rand Group can help. Our software selection and implementation services help you choose the right solution and ensure it’s deployed effectively to support your goals.

Rand Group has over 20 years of experience, 1,000+ clients in North America, and deep expertise in the industry. That makes us uniquely positioned to help finance teams navigate clinical trial accounting. Our consultants understand regulatory requirements, operational challenges, and the strategic importance of accurate financial data.

We do more than implement software. We align technology with business objectives to optimize business operations, ensure compliance, and support operational excellence.

Clinical trial accounting is one of the most complex financial functions in life sciences. However, with the right ERP solution and a trusted implementation partner, it does not have to be a burden. Whether you choose Oracle NetSuite ERP, Microsoft Dynamics 365 Business Central, or Dynamics 365 Finance & Operations, Rand Group can help streamline trial spend tracking, automate accruals, and maintain regulatory compliance.

Ready to simplify your clinical trial accounting? Contact us today to explore your ERP options and learn how we can support your journey from research to commercialization support.