Maximize clinical trial accruals accuracy in 2023

Q4 is hectic: planning for the year ahead collides violently with the needs of ongoing projects and time away for upcoming holidays. Yet some issues demand year-round attention, including the perpetual need from Finance and Accounting teams for a real-time, unified view of clinical trial contracts, activities, and changes.

In a recent survey that gauged the biggest challenges in clinical trial financial management, a near majority (43%) of biotech finance and accounting leaders identified clinical trial accruals as their largest hurdle, trailed by vendor accountability with 27% of respondents and R&D forecasting/runway management with 14%.

For anyone who has managed clinical trial accruals, this may come as no surprise. Investigator payments and grants, which may be 40-50% of the overall cost of your trial, converge in a complex and outsourced ecosystem that may be spread across geographies, sites, and third parties. Even studies with a small patient population (i.e., rare disease) are costly and data rich. Patient spend can be six figures per patient while the volume of data on procedures and visits balloons quickly. For larger global studies encompassing 50 to 100+ sites, the complexity is nearly exponential. If a sponsor’s financial modeling doesn’t incorporate real-time and clinically-driven updates, a great deal of money can be spent without clear and timely visibility. Accrual accuracy is vital to the health of your study or company: low estimates can lead sponsors to spend more than they have and fall short on capital to cover their commitments; high accrual estimates limit cash flow and program investments unnecessarily. Take a moment to consider: might the accuracy of your accruals be impacting your corporate decision-making? And, might a lack of control, blurred visibility and overreliance on vendor estimates put your organization at risk of material misstatement?

Auxilius was created to address this need. It’s a cloud-native FP&A and accounting platform that ingests data from across the enterprise – from contracts and invoices and budget grids to EDC/CTMS feeds – to offer you a comprehensive driver-based forecasting, accruals management, and financial intelligence toolset. Importantly, Auxilius was purpose built for clinical trials, meaning that key industry-specific functionality like investigator expense accrual calculations is baked in from the start.

When appraising a software solution like Auxilius for your clinical trial accruals, consider the following questions as you chart a course for the year ahead:

• Are my current processes largely reliant on Excel or industry agnostic tools?
  Not surprisingly, nearly 40% of sponsors report that Excel fails to meet their forecasting needs due to protocol complexity, limitations in data interoperability, reforecasting difficulty, and error-prone models. While Excel is a default approach, it presents compliance risks due to flexible data, a lack of change record or audit trail, super user/workbook owner dependencies, and no source-document trail to ensure the right inputs are generating the right outputs for key audit and forecasting functions. Additionally, industry-agnostic tools and spreadsheets may lack the ability to automate complex workflows like investigator accruals or lack compliances-specific features like user-based permissioning and audit logs.
  
  
• How have you codified your process for accruals each month and ensured it remains consistent? 
  Our system ensures best-in-class, complaint accrual processes by aligning clinical and financial teams + data within the product while creating a system of consistent requirements – custom checks for clinical trial accruals – that must be completed each time before closing the period. 

• Are multiple functional leads involved in generating accruals?
  The power of a platform allows for department-specific access - meaning functional leads from accounting, ClinOps or finance can operate in the same environment with the same data and understanding of current trial and financial progression. This not only speeds up the accrual process but decreases room for error due to misunderstandings or divergent data. 

• Do you have manual data entry from multiple systems used in your accrual?
  Integrations and ingestion from key data sets across financial and clinical increases the speed of the accrual process, decreases manual data transfer risk, and ensures you're aligned across what you're spending/accruing (clinical) and how much you're spending/accruing (financial).

• Are you having regular conversations with your CRO and key vendors around progress on your trial?
  Auxilius equips you with the tools you need to drive accountability and oversight of vendors on an ongoing basis. Communication is good – but communication with reliable historical data is even better and will help shine a spotlight on underperformance. 

• Do you use vendor estimates, forecasts, or other datasets in your accrual process?
  To accurately gauge the financial state of a trial, sponsors are confronted with a tough choice: should they rely on third party estimates, or should they build their own internal view? Our research indicates that biotechs split evenly on the issue: 54% report using an internal view while 46% use vendor estimates. We posit a third option: The Auxilius system supports various comprehensive inputs to your accrual – including clinical data sources such as IRT, EDC and CTMS reports and systems –, allowing you to both compare across datasets to arrive at the most accurate accrual number and trace all inputs into the system clearly to their resulting accrual and forecast outputs. The result? The best available evidence to inform your accrual calculation. 

• Are you updating accrual methodology based on past performance?
  With a consistent record of accruals – both over time and against expectations (initial, forecast, etc.) – you gain insights needed to adjust your methodology and increase your accuracy in financial processes. Auxilius ensures not only that your accruals are compliant, but that they are an accurate reflection of historical and expected spend to help support your financial decision-making and strategy going forward. 

• Do you have stakeholders that you need to communicate accruals with on a particular cadence?
  Auxilius supports data-sharing across your organization, within the product’s simple, easy to reference platform interface that ensures everyone in the organization is “speaking the same language” and outside our system structure, allowing for exportability and reporting across external or executive stakeholders.

And there’s much more to consider… Although broad, these questions may resonate with your experience of managing clinical trial accruals. For more information on our approach, check out the resources below:

• The clinical trial accruals tradeoff: a false choice
• How to manage clinical trial accruals with Auxilius

However, seeing is believing. Click here to request a personalized demo of the Auxilius platform and stay one step ahead of an accruals headache in the year to come.