"We rely 100% on Auxilius and our auditors are more than happy with it.”

The Challenge: Addressing the limits of manual, Excel-based processes at scale

"We were approaching clinical stage and Excel sheets quickly started to become cumbersome. Models start cracking and breaking, or just become a pain. So we began looking for systematic solutions."

Shifting from pre-clinical to clinical, and focused on public market preparedness, PMV recognized the need to re-think study-level financial processes. As the company prepared to scale clinical programs, the finance team foresaw the limitations of managing processes manually in excel:

• Difficulty conducting project-level tracking, versioning, and scenario modeling at scale.
• Insufficient granularity and detail around vendor estimates and budget grids.
• Difficulty surfacing certain variances (e.g. accrual estimates) quickly or in context.

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The Solution

Mike Carulli, PMV’s SVP of Finance, was responsible for building an effective process for accruals and forecasting, but without the perks of staffing or spend of big pharma. When Mike joined the team at PMV in the spring of 2020, he brought a decade’s worth of enterprise R&D finance experience from Celgene, giving him a unique lens from which to guide his team.

In early 2022, Mike identified Auxilius as a solution capable of managing study-level forecasting and accruals across vendors, investigators and sites. He wanted to move his team to the platform, but needed his auditors to embrace the new system. Here’s how he broke down the process:

1. Employ a staggered and strategic roll out

After a short initial implementation period for the Auxilius solution, Mike and his team were off to the races. Since they were mid-trial, they maintained their excel model in parallel to ensure a seamless transition, while validating that the Auxilius solution was calculating forecasts and accrual estimates correctly. Dependent on a number of disparate tools and data sources, ensuring that the entire technology stack is in sync was critical.

After comparing outputs from Auxilius against their legacy processes, the PMV team was quickly comfortable that the tool was calculating forecasts and accrual estimates correctly -- producing predictable, accurate, and reproducible results. In October 2022, they transitioned completely.

Looking back, Mike believes he could have transitioned even sooner. But for PMV, running parallel processes allowed their team and auditors to get comfortable with the Auxilius platform. The intentionality of his approach paid dividends -- ensuring alignment and trust before go-live.

2. Communicate with auditors early and often

Mike notified PMV’s auditors early-on that they would be making the transition from the legacy excel model to the Auxilius solution. Keeping communication lines open, providing examples/ exports and illustrating that forecast methodology remained consistently applied, Mike and the PMV team found success in driving auditor comfort.

Results

Though it wasn’t a surprise, the auditor liked the end results. Beyond comfort with the accuracy and reliability of the platform, EY also identified a number of additional benefits:

• More granular management (at the vendor grid level)
• Additional data points incorporated into the accrual estimation model
• User-based permissioning and controls
• Consistently applied methodologies, and a real-time audit log designed to track any deviations or changes, the impact of those changes, who made them, and why