From Surviving to Thriving: Healthy Compliance in One Year

Our global biopharma client has revolutionized medicine, developing new treatments for cardiovascular and neuromuscular diseases. By leveraging expertise in the mechanics of muscle function, the late-state biopharmaceutical company is innovating treatments for those impacted by heart failure and ALS, among others. And with over 60 publications, more than 50 clinical trials, and hundreds of issued patents, they are also accelerating innovation in the research space.

Since the Sarbanes-Oxley (SOX) Act was passed in 2002 to protect investors from fraudulent financial reporting, companies large and small have been required to regulate their financial practice and corporate governance by developing, testing, and remediating internal controls. To comply with the legislation, our client had previously engaged an outside vendor—one who did not escalate the problem areas the company faced with their internal controls. As the company closed out FY2018, it became clear that the health of its internal controls systems was suffering, and it needed to quickly mobilize a reliable defense.

When RGP was brought on board in 2019 to remedy the situation, the company had more than 20 deficiencies—and a material weakness they were obligated to note in their 2018 10K. During our engagement, our client implemented the Oracle Fusion cloud-based ERP system, which also made it possible to automate key process controls.

“Because of RGP, we are at a point where all of our controls are documented in a way that, moving forward, allows us to scale up opportunities and still maintain compliance.”

Led by Alisanne Allen, VP of Governance, Risk and Compliance, our team knew the solution not only required designing better controls but also evaluating the enhanced efficiency that became feasible with the new ERP system and fostering better communication with management and the Audit Committee.

“Our priority was in forming a solid partnership, one where we could create transparency around problems, in order to collaborate around solutions,” Alisanne says.

Partnering to Build a Well-Oiled Workflow

RGP partnered with the company to discuss remediation options, formulate solutions, propose control redesign, and test the operational effectiveness of the remediated controls. We also partnered with the outside auditor, whose job was to attest to the effectiveness of the controls that management put in place. This approach proved to be a game-changer for our client.

“It’s not a one-way street with RGP,” says a representative for the company. “The team was constantly trying to understand what the issues were and was committed to helping us look at processes. It’s a true partnership. We would propose a solution, they would look into it, make suggestions and incorporate our feedback for a truly collaborative process. We felt like they were on our side.”

In total, Alisanne and her team identified and assessed the needs for more than 35 control changes across multiple business processes, updated flowcharts, and tested the new controls.

Taking advantage of the new ERP capabilities, the company was also able to consolidate processing and financials into one centralized system. Our work not only solved for the company’s former deficiencies, but also supports continued business growth.

“Because of RGP, we are at a point where all of our controls are documented in a way that, moving forward, allows us to scale up opportunities and still maintain compliance,” our client says.

With a well-oiled workflow, supported by reliable internal controls, our client can focus on the important work of developing much-needed therapies. And in areas where they previously suffered, they’re now thriving.

“By working with RGP, we were able to resolve most of our control deficiencies,” our client says. And about that material weakness the company was previously obligated to report on their public filing? “We no longer have any material weaknesses.”

“It’s not a one-way street with RGP. The team was constantly trying to understand what the issues were and was committed to helping us look at processes. It’s a true partnership.