Dynamics 365 provides solid financial tools and more for Clene Nanomedicine

RSM gives Clene, Inc. a solid financial reporting base and tools to scale into production

Apr 05, 2023

Going public in December 2020 was a big step for early-stage biopharmaceutical company Clene, Inc. in its work to revolutionize the treatment of neurodegenerative diseases and protect neuronal health and function. But it was just one of several steps that highlighted the need for the company to upgrade to a robust enterprise resource planning solution.

As RSM was brought in to assist Clene, clinical trials were already in progress for the company’s platform, which enables the creation of nanocrystals for therapeutic use in areas of high unmet medical needs—such as neurodegenerative diseases and other areas like antiviral, antibacterial, wound healing, burn treatment and oncology. That ongoing progression from early to clinical stage had entailed increasing internal complexities.
Moreover, the company decided it wanted to manufacture its own products rather than outsource that function as many other pharmaceutical companies do.

Clene’s team philosophy is that with the right mix of experience, expertise and creativity, they can change the landscape of clinical development.

As the need for tighter internal controls became evident, Clene initially reached out to RSM for advisory services based on a prior relationship. Since Clene was using QuickBooks as its accounting system, which initially had served its needs adequately as a private company, it became apparent that this system would need to be replaced. Clene turned again to RSM’s management consulting team to assist with the ERP selection, seeking a system that would better address its financial reporting needs. After a thorough review process, Clene chose Microsoft’s Dynamics 365 Finance & Supply Chain (D365) ERP application, which would clearly enable its future growth. RSM was again also selected to help implement the system together with Clene’s staff.

RSM went out of its way to understand our business, our future goals and the way our team functions together. That enabled RSM to deliver a solution that not only met our most immediate financial reporting needs but also set us up for long-term success as we strive to become a fully functional pharma with approved and marketed products in the future.
Trevor Johnson, VP Finance and Controller, Clene, Inc.

Supporting needs beyond financial compliance

Because Clene already had several products in clinical trials—in anticipation of eventual FDA approvals—and intended to manufacture its own products, RSM realized early that Clene needed a broader solution beyond a better accounting and financial reporting system. Instead, it needed an ERP solution that would scale and grow with the company, particularly around manufacturing in the future.

Clene recognized that as a growing enterprise, it would need a robust infrastructure to meet significant
compliance and regulatory requirements related to the FDA, as well as to support other operational and functional needs. Ultimately, after exploring and comparing several vendors and products, Clene chose Microsoft Dynamics 365 because it could accommodate a wide variety of operational needs such as financial, reporting, workflow, and supply chain along with many others. For the most part, the other solution providers tended to be more focused toward financials or operations rather than taking a holistic approach and did not offer the necessary coverage with scalability.

Working together to execute Clene’s corporate vision

RSM’s commitment to the Life
Sciences industry was an important
factor in Clene’s decision to choose
RSM and one of the primary reasons
for the ultimate success of the
Dynamics 365 implementation. RSM’s
advisors thoroughly understood
Clene’s industry-specific challenges
and brought resources to bear
that allowed the team to connect
with stakeholders throughout the
company—not just in finance, but
also on the operational side—to
understand Clene’s company-wide
requirements holistically.

Clene went public quickly through
a de-SPAC process, and as the
company’s leaders were building their
team and their processes, they rapidly
recognized a need for support to
generate reliable financial information
and build on their infrastructure.
Dynamics 365 provided Clene with a
solution that enabled it to consolidate
all its systems and business processes
into a single system of record, while
also making it easier for Clene to meet
SOX compliance and other regulatory
and financial requirements.

The existing systems that had carried
Clene to its initial public offering
no longer integrated well with its
existing processes, much less the
company’s plans. For example, Clene
had multiple legal entities under
its corporate umbrella, and one
part of its operations functioned in
Australian dollars, which Clene had to
convert into U.S. dollars for reporting
purposes. Migrating that data into
Dynamics 365 and consolidating it
was a particular challenge in a project
with such a short time frame.

Even though Clene had begun the
project just trying to improve its
accounting and financial reporting,
the company ended up with a system
that could scale into much more.
Regardless of whether the company
ultimately carries out its plan to
manufacture commercial products
in-house, switches to outsourcing or
pursues a hybrid model, Clene is now
capable of operating on all three of
these fronts without having to bolt on
several solutions from other vendors.

The value of working with RSM

Working together, the Clene and RSM teams were able to deliver rapidly on Clene’s needs over the course of the project—and provided more value faster than expected. Originally a 12-week project that included the Thanksgiving and Christmas holidays, the functional time frame was essentially shortened to just a little over eight weeks with both teams enjoying their holidays.

Because of the aggressive time frame, RSM and Clene had jointly agreed to remove certain items from the original project scope, one of the most notable being not to implement the fixed assets modules as part of Dynamics 365. Clene decided it could do without that functionality at go-live by maintaining its current processes until a phase 2 project with RSM. However, the project went so smoothly that RSM and Clene were able to incorporate the fixed assets module during phase 1 after all. RSM also implemented workflow functionality features that helped with systematic approvals in general journals.

Dynamics 365 has already aided Clene from an internal control standpoint as a public company, helping it be more compliant and have more control over its financial reporting. While there was an initial learning curve involved in switching from QuickBooks to Dynamics 365, Clene was able to close its financials more efficiently than before. The system is now scalable to near-term needs and poised for future growth and complexity, positioning Clene for a potential second phase of ERP work with RSM, assuming FDA approvals come out of one or more of Clene’s clinical trials. Potential future work would focus on modules for inventory, supply chain and manufacturing needs.


"Because they had already committed to being a manufacturer of their drug, they needed a system that would address the heavy lifting of manufacturing, distribution and potentially track trace. In the pharma world, there are looming, hard compliance scenarios around that. D365 was an obvious fit for their ERP and finance needs."

Ron Wetter, Microsoft Life Sciences Industry Leader, RSM US LLP



“Even though we had a compressed time frame to complete the project, RSM not only gave us what we needed but also fit additional requests into our project that we thought we’d have to go without for a while—and RSM did everything on time and within budget.”

Sally King, Senior Manager, Financial Planning & Analysis, Clene, Inc.



“Dynamics 365 consolidated our information, aided our reporting and accounting needs and improved our workflows. All of that has helped to set us up for success both now and in the future.”

Lachlan Macintosh, Assistant Controller, Clene, Inc.


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