How to Build Effective Collaborations with ClinOps

At clinical stage biopharma companies, successful collaboration between Clinical Operations (ClinOps), Finance, and Accounting is crucial for maintaining a complete and accurate picture of a company's financials. However, barriers can hinder effective coordination. Below, we outline key challenges and strategies to foster collaboration, drawing from Auxilius' experience with clinical-stage biopharma organizations and sharing insights on improving collaboration between ClinOps, Finance, and accounting.

Common barriers to cross-functional collaboration

 

Finance and accounting teams typically requires information from ClinOps to understand what happened in the study (to inform accruals) and what is expected to happen (to update the forecast).

This includes: Number of patients enrolled, changes in expected enrollment, change order progress, protocol amendment updates.

 

This information is typically conveyed in meetings and/or written communications across teams. However, across all organizations that we work with, there are three common barriers to effective collaboration and knowledge transfer between ClinOps and accounting/Finance:

1. ClinOps is swamped: ClinOps teams are on the front lines operating the trial, managing patient recruitment, site relationships, protocol amendments, and ensuring compliance. These extensive responsibilities leave them overwhelmed, limiting their availability to provide timely updates to finance and accounting.

2. The information isn't in one place (or it's in ClinOps' head): Information required by finance and accounting is often scattered across multiple systems or, in some cases, not documented at all. This creates inefficiencies and makes it difficult to get a complete picture.

3. There aren't any dollars attached to clinical insights: Clinical data, such as patient recruitment numbers or protocol amendments, are often not directly tied to financial figures. This makes it challenging for finance to understand the financial impact of clinical operations without significant manual effort.

As an example, we have a client at Auxilius where there's one main ClinOps person staffed on the team, traveling all over the world to activate trial sites. She doesn't have time to get back to the controller with his questions, but he can't access the site contracts to understand what is owed. He knows there are twenty patients screened, but it's unclear what the financial obligations are because of that.

As you'd imagine, he had huge challenges getting the information he needed to developing complete and accurate expense estimates while allowing ClinOps to focus on patient-centric work.  

Strategies for effective collaboration

 

While there isn't a single set of best practices for effective collaboration between ClinOps, accounting, and finance, there are several different practices that teams have deployed successfully to meet the needs of their business. These typically involved different meeting cadences and structures.

• Weekly Meetings: Weekly touchpoints between accounting/finance and ClinOps can be helpful when clinical trials are in critical phases, such as patient enrollment or site activation. During these periods, timely communication is essential to ensure that finance stays informed about costs associated with rapid operational changes. For example, one Auxilius customer was in protocol amendment negotiations and had stopped enrolling patients. Weekly meetings helped ensure that finance remained aware of the impact on costs and timelines during this transitional period.
• Quarterly Meetings: Quarterly or monthly meetings can be helpful for organizations with less complex studies to prep for period close and/or audits.
• Ad Hoc Meetings: Occasionally, ad hoc meetings can be scheduled as needed to address unexpected issues or urgent changes that require cross-functional input.

Regardless of the meeting structure, we've found that organizations with effective collaboration establish communication structures and processes up-front to facilitate them (e.g. Building a SharePoint that ClinOps manages, aligning on how the teams will use Auxilius to share information.)

Auxilius as a collaboration tool

Auxilius is designed specifically for biopharma companies to manage their clinical trail budgets, forecasts, and accruals. Because Auxilius ingests clinical data and marries it with financial and budget data, Auxilius is a valuable tool helping Finance, Accounting, and ClinOps teams save time and collaborate more effectively.

Teams that use Auxilius to collaborate cross-functionally typically see three benefits:

1. Little to no prep time: Instead of lengthy prep and creating special materials, teams can just pull up key pages in Auxilius and modify the data live as a team.

2. Single source of truth: Auxilius brings different sources of information into one system, allowing you to compare, modify, and select the best source of information in lieu of maintaining multiple trackers across teams.

3. Activities translated into dollars: Clinical activities, such as patient enrollment or site activation, are automatically married with trial budget data and translated into financial figures within Auxilius. This helps teams easily understand the cost implications of clinical trial developments, allowing for more efficient and effective budget tracking and forecasting.

Additionally, there are three practices that we've seen work well when it comes to using Auxilius to improve collaboration between finance, accounting, and ClinOps:

• Use Auxilius as your source of truth: In lieu of multiple trackers, use Auxilius as the source of truth for clinical and financial information and have ClinOps go into the platform as-needed and input / validate what's going on in the study.

• Use Auxilius as a communication tool vs. making separate materials: Use pre-built views within the Auxilius platform (e.g. in-month adjustments page, change orders page) instead of prepared materials to boost efficiency and collaboration

• Engage with the system in real-time: Upload change orders, protocol amendments, and other updates into the system as they come in (vs. in batches) to provide teams with the most up-to-date information on the study.

Many Auxilius customers have replaced the hours spent preparing 20+ slide decks for ClinOps meetings by simply using the in-month adjustments page in Auxilius. This approach allows the team to review and discuss updates in real-time, saving significant preparation time and effort.

If you want to learn more about the Auxilius platform, feel to reach out to a team member and we'd love to talk more!