Dynamics 365 provides solid financial tools and more for Clene Nanomedicine

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.

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.

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.

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.