Immuneering Corporation is a late stage clinical oncology company advancing Atebimetinib, in combination with chemotherapy, into a pivotal Phase 3 trial for first-line pancreatic cancer patients—a high-unmet-need indication. But as the trial design grew bigger and more complex from Phase 2 to Phase 3, so did the complexity of managing aspects of its financial operations.
Christian Alaia, Senior Director of FP&A, sits at the center of that challenge. Operating in a dual capacity, Christian oversees long-term budgeting and cash runway forecasting while also overseeing the monthly close process, including managing clinical accruals. It was at this point that Christian realized the manual processes that had supported earlier trials could not scale to meet the demands of a much larger Phase 3.
Clinical trials are complex in nature. Oncology trials take things even further, with high per-patient costs, variable cycle lengths, unpredictable follow-up visits, and extensive variable expenses like CT scans and MRIs. Layered on top is the "black box" of standard-of-care insurance billing: sponsors may be unable to accurately predict which procedure costs a site will bill to insurance versus pass through directly to the sponsor.
Potential site invoicing lags may compound the problem. It’s not unheard of for site invoices to arrive two to three years after work has been performed, costing hundreds of thousands of dollars that were not planned for.
“The biggest potential issue with what a CRO often provides is that it's just a payment report,” Christian said. “In such cases, it's fully reliant on the site invoicing timely, and that's where there's a big lag.”
Invoice rejections created a further wrinkle: "if a site sends a large invoice and the CRO rejects it for some reason, even something small, the entire invoice can fall off the payment schedule. So it may look like expenses just dropped by hundreds of thousands of dollars, when in reality that should still be an accrued cost."
Christian had seen this play out before. "At my previous company prior to joining Immuneering, we had a full-time headcount solely responsible for R&D accounting," Christian said. He didn't want to repeat that model at Immuneering. And while Immuneering’s existing process worked well enough through Phase 2, he thought it could be improved for the pivotal trial setting: “the model that we created was not readily scalable” heading into Phase 3. Immuneering wanted a different path: software built for clinical trial finance that gave granular control without adding full-time overhead.
The evaluation was thorough and cross-functional. Finance and Accounting were looking to “keep our monthly close accurate, keep our auditors happy, and to have a good efficient process for forecasting.” Clinical Operations was involved in the evaluation to ensure they saw value in the platform. Leadership also required a strong business case before committing: as Phase 3 approached, the team needed to show that they could maintain an accurate close process and satisfy auditors without taking on additional risk. Immuneering also evaluated other Clinical Trial Financial Management solutions, but found that the Auxilius platform was the preferred solution with sufficient granularity on the investigator grants side.
After a successful fundraise that secured capital forecasted into 2029, the Immuneering team moved forward with starting up their new Phase 3 and managing study financials on the Auxilius platform.
Software implementation moved quickly, supported by Auxilius's team which included a dedicated implementation lead, with support from clinical data experts, former biotech finance professionals and ex-Big Four auditors. From an auditor perspective, the transition was seamless: “Everything was made super clear for the auditors. They haven't had any problems or additional questions with the system to date.”
A real turning point came when Immuneering connected de-identified and aggregated EDC (electronic data capture) data directly into Auxilius. Rather than waiting for site invoices or CRO reports, the finance team could see actual patient visits, scans, and procedures as they happened, and map that activity directly to site budgets to accrue costs in real time.
"Connecting to EDC for visibility into scans and procedures was huge... and it's given us visibility into potential costs that otherwise might have caught us by surprise"
For Immuneering, so far the shift has meant fewer surprises and more confidence accounting for their Phase 3 trial, with improved ability to close the books and plan cash runway. To learn more about how Auxilius can bring control and confidence to your clinical trial budgets, forecast and accruals, book time with us here.
Immuneering Corporation is a late stage clinical oncology company advancing Atebimetinib, in combination with chemotherapy, into a pivotal Phase 3 trial for first-line pancreatic cancer patients—a high-unmet-need indication.
