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Investigator Reconciliation Breakdown

In a recent live session, Auxilius President and COO Erin Warner Guill and Head of Customer Operations Kristen Lueck led an open discussion on the challenges with investigator reconciliation today and how companies are automating this process with Auxilius. Below are the themes from this discussion.

For the full session recording, reach out to Peter at pkinchley@auxili.us

Audience Poll: The state of reconciliation today

During the session, attendees participated in a live poll regarding their current reconciliation practices:

Half of the respondents indicated they manage 25-75 sites, with 18% overseeing 100 or more. Larger site counts is typically associated with more complexity and time needed for manual payment reconciliation.

The majority (68%) of respondents reported regularly reconciling payments, though a notable percentage (32%) indicated that they either perform only spot checks or do not reconcile at all. This highlights the widespread need for more efficient and accurate reconciliation methods.

The Challenges with Manual Reconciliation

“The biggest issue is their reports to us, which as you mention have many inconsistent names, and they are quite simple spreadsheets, where they could do a better job of grouping types of invoiceable visits, etc.”

Investigator spend is inherently volatile and therefore challenging to account for. Protocol changes, complex reimbursement dynamics and costs outside of the schedule of assessments, or “invoiceables”, are common across clinical trials. This unpredictability poses significant challenges for accounting teams striving for financial and operational clarity.

Sponsors face two key hurdles:

  1. The Accounting Challenge: Ensuring financial statements accurately reflect expenses.
  2. The Operational Challenge: Reconciling invoices to confirm that charges align with actual trial activity.

These challenges have two main implications:

  1. In the weeds: Missing invoices or over-billing at the day-to-day level
  2. At the strategic level:  A potential misallocation of capital or even misstating expenses

Traditionally, there have been manual approaches to validating the accuracy of site payments that manage the tradeoff of efficiency vs. accuracy:

  • The lower touch approach (efficiency): Sponsors spot check the payments report against enrollment.
  • More comprehensive approach (accuracy): Sponsors go through the effort of building their own internal source of truth for site costs in the form of a patient tracker with cost detail (this is often a time intensive process requiring accounting or clinical teams to spend significant time building complex Excel models).

Other trends noted in the discussion

Several attendees raised concerns about inefficiencies in reconciliation processes, including:

  • Data inconsistencies: One attendee noted, “The biggest issue is the inconsistency in naming conventions across reports. It makes simple spreadsheet checks ineffective.”
  • CRO Assumptions: Another participant shared, “We’ve been informed that CRO study assumptions driving reconciliations aren’t always up-to-date or reflective of current contracts. How can we address this?”
  • Regional Variability: Others pointed out that some European sites take significantly longer to submit payment data compared to those in the US or Canada, impacting financial planning.

The Role of Vendors

“We have been informed by some of our CRO's that their study assumptions that drive the reconciliations aren't always up-to-date and reflective of the current contract and protocols. This is unfortunately out of our control obviously.”

Contract Research Organizations (CROs) often play a pivotal role in managing the site payments, and therefore, could and should theoretically provide the financial reconciliation. Some CROs provide detailed invoices, while others report primarily in lump sums, making thorough reconciliation difficult. Some session participants noted that this lack of detailed billing line items is a widespread issue, complicating efforts to track spending accurately.

Additionally, some organizations have sought greater control over invoiceables by using third-party payment providers, requiring invoices to be approved in a portal before payments are made. However, even with these measures in place, sponsors remain reliant on CROs for accurate study assumptions that drive reconciliations. Some session participants shared that their CROs’ assumptions are not always up to date or reflective of current contracts and protocols, creating further challenges that sponsors often have little control over.

Ensuring that CROs include specific data fields in their reports and maintaining active oversight can help sponsors cross-reference payments with internal records more effectively.

In the discussion it was recommended to request specific data fields from CROs to make any reconciliation possible, including:

  • Site ID
  • Patient ID (de-identified)
  • Visit description
  • Date of service
  • Date of billing
  • Payment status

The Power of Automation

Breaking the Trade-Off Between Efficiency & Accuracy

Automating the reconciliation process with Auxilius offers a transformative way to break the trade-off between efficiency and accuracy in accounting. By building upon Auxilius's Investigator Spend Intelligence module and leveraging intelligent data mapping and flexible matching logic, organizations can significantly reduce the time and effort required for manual reconciliation.

Auxilius eliminates this trade-off by building off its Investigator Spend Intelligence module, which:

  • Automatically maps clinical transactions to site payments using intelligent data matching.
  • Identifies inconsistencies across data sources without requiring manual intervention.
  • Reduces reconciliation time significantly, allowing teams to focus on higher-value activities.

Auxilius Investigator Reconciliation has been shown to match a high percentage of site payments to clinical transactions, overcoming challenges like data inconsistencies and varying naming conventions that can complicate manual efforts and render vlookups ineffective.

Three Actions Sponsors Can Take Today:

  1. Enhance CRO Oversight and Request Specific Data Elements: Request more granular payment data fields and set expectations for study assumption updates.
  2. Prioritize Reconciliation Early & Often: Regular reconciliation prevents year-end surprises and reduces the risk of misstated expenses.
  3. Explore Automation with Auxilius: Eliminate manual reconciliation inefficiencies with AI-driven matching and real-time visibility into trial spending.