Clinical trial financial management is undergoing a structural shift. Rising R&D costs, tighter access to capital, and heightened audit scrutiny have pushed trial economics into the center of strategic, financial, and operational decision-making. What was once a quarterly reporting exercise is now a core determinant of credibility with investors, auditors, and leadership teams.
Auxilius’s Erin Warner Guill recently sat down with Ousmane Caba, Life Science Audit Partner at PwC, to discuss what’s driving this change and what organizations must do to keep pace. Below are key themes from that discussion.
“It’s really important to bring in that audit perspective,” Caba said, noting that expectations around clinical financials have expanded dramatically.
He explained that organizations are operating in an environment where scrutiny is increasing across all dimensions: investor due diligence, audit cycles, and internal capital allocation. “Clinical trial financial management is today’s strategic priority,” he said. What used to be a routine compliance activity now determines whether companies can articulate a clear financial story, defend their assumptions, and plan capital with accuracy.
Caba emphasized that the pressure is coming from several directions at once. Investors want confidence in runway and burn. Auditors expect repeatable, supportable methodologies for accruals. Boards are requesting deeper explanations for swings in R&D spend. This convergence has fundamentally changed the expectations placed on finance, accounting, and clinical operations teams.
“To absolutely be able to drive capital efficiency, you need radical transparency into your R&D spend,” Caba said.
He noted that transparency now requires a far deeper understanding of cost drivers than most organizations have historically maintained. Companies need to know where trial dollars are moving in real time — across sites, vendors, geographies, and program phases — and they must be able to reconcile this activity back to what appears on the financial statements. In his view, this level of insight is no longer optional.
Caba highlighted that operational and financial systems often tell different stories, which creates inconsistencies that are hard to defend. “What we find is one of the best things that we’re bringing to our customers is structured data assets that you can interrogate,” he said. These assets allow teams to understand where spend is concentrated, identify patterns in over- or under-invoicing, and trace discrepancies to their operational origins. Without this transparency, he warned, companies risk unpredictable accruals and weakened credibility during audits and fundraising.
Accurate actuals remain the foundation of financial integrity, but they are increasingly difficult to produce.
Caba explained that many organizations still struggle to obtain timely, consistent data from sites and vendors. Complex outsourcing models create long reporting chains, and organizations often need to estimate significant portions of their incurred costs. “Capital efficiency and runway visibility is very important in today’s fundraising environment,” he said, underscoring how sensitive investors are to the quality of R&D numbers.
He added that inaccurate actuals cascade through the financial system — distorting accruals, complicating variance explanations, and triggering deeper audit questions. When methodologies rely too heavily on judgment rather than evidence, audits become more time-consuming and disruptive. The organizations performing best, Caba noted, are those investing in structured data, automated reconciliations, and clearly documented estimation frameworks.
“I think the key with capital efficiency is all those functions have to be in alignment,” Caba said. “And you actually have to be in alignment based on the shared data and shared view of what’s happening in your clinical portfolio.”
He emphasized that misalignment remains one of the biggest barriers to financial accuracy. Clinical operations often manage enrollment, site cadence, and trial-level complexity. Finance builds forecasts based on historical spend or budget targets. Accounting closes the books using invoices and accruals. When these perspectives diverge, financial results become inconsistent and difficult to defend.
According to Caba, the strongest organizations maintain a unified portfolio view — one set of numbers, one set of assumptions, and one shared understanding of trial activity. This alignment strengthens forecasts, accelerates monthly closes, and ensures that variances can be explained using operational drivers rather than manual adjustments. Without this shared view, capital planning becomes less reliable and more reactive.
“Data is gold now,” Caba said, pointing to the rapid shift toward treating financial and operational data as a strategic asset rather than a byproduct of trial execution.
He explained that structured, consistent data is the single biggest unlock for organizations aiming to modernize their financial management. When data is normalized, integrated, and easily interrogable, teams can confidently explain trial-level economics, model scenarios, and support audit testing. When data is fragmented — across spreadsheets, outdated systems, or inconsistent vendor files — financial management becomes slower, riskier, and more error-prone.
Caba emphasized that the value of data is not just in visibility, but in the clarity it brings to decision-making. With reliable data, companies can pinpoint inefficiencies, improve forecasting accuracy, and create narratives that resonate with investors and auditors. Without it, organizations face delays, rework, and difficulty defending their numbers during periods of heightened scrutiny.
Investors and auditors are converging around the same core expectations: consistency, transparency, and discipline.
Caba said stakeholders want to see numbers that reconcile across systems, methodologies that are supportable, and management teams that can articulate where dollars are going — and why. “Radical transparency into your R&D spend is critical,” he reiterated, noting that the companies who can deliver this level of visibility gain trust and, in turn, better access to capital.
He added that today’s environment rewards organizations that demonstrate control and stability. Those that rely on opaque processes or heavy judgment face increased scrutiny, longer audit cycles, and reduced flexibility in fundraising. As capital markets remain selective, Caba sees transparency and operational discipline as essential for navigating the next phase of industry evolution.
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