Case Study

Helping a Gene Therapy Company Accelerate Growth and Scale Effectively With NetSuite

SUMMARY/OVERVIEW

Moving From Startup to Clinical Trials

Developing cutting-edge gene therapy treatments is a massive undertaking. The science behind conducting research and performing clinical trials requires extensive knowledge and resources. But that work is only part of what it takes for a life sciences company to grow and succeed. Managing the numerous facets of gene therapy development — including finances, manufacturing, controls, and GMP (good manufacturing practices) compliance — requires a cohesive platform capable of scaling with a business as its needs evolve and grow. This was the challenge facing one BDO client working its way from their initial funding phase as a startup to clinical trials as a publicly traded company. Needing a scalable solution that could address their strategic growth goals, the client sought our help in moving from its basic finance and accounting software to a more robust platform that integrated with every area of its business.

Key Takeaways

Scalable growth

Scalable platform that grows over time as the company’s needs evolve. 

Compliance tracking

Compliance requirements tracked and verified in the system that serves as a single source of truth. 

Affordable solution

Affordable solution that costs a little as 10% compared with ERPs designed for larger organizations. 

Lab employees assessing results
The Challenge

Finding a Platform for Compliance and Operational Efficiency

As the company transitioned from Series B funding to clinical trials, the accounting software it had been using was no longer sufficient. The client needed a platform that would allow it to efficiently manage the next phase of its development, such as supply chain and  manufacturing operations. The software solution also needed to help manage and track regulatory standards, including Sarbanes Oxley (SOX) and GMP compliance. It was also important for the platform to be easily managed by a small team, with the ability to scale to meet company growth. 

Close-up of DNA
The Approach

Expanding Capabilities To Meet Strategic Goals 

We started by assessing the client’s needs, helping them work through the change from the startup stage to one of commercialization. From the outset, it was clear that automation and efficiency tools were essential to the company’s long-term vision and strategy. We recommended implementing NetSuite as the client’s enterprise resource planning (ERP) platform, leveraging BDO’s Life Sciences functionality built into the software, which offered several benefits that addressed key areas of functionality specific to the industry and critical to the reaching their goals. 

One of those benefits was usability, thanks in part to NetSuite’s scalable nature. Unlike some ERPs designed exclusively for larger enterprises, NetSuite is capable of meeting the needs of smaller teams and scaling with them as they grow, making client’s transition from its prior accounting software a more natural adjustment. Its user-friendly structure meant that a small group could easily work with the most relevant features of the software, activating additional capabilities as the team’s needs evolved. Additionally, NetSuite was a more cost-effective option than other ERPs with functionality specific to life sciences companies. 

NetSuite’s design also presented advantages from a data governance perspective. Because the platform is already a well-structured database out of the box, it establishes parameters for users when creating and saving information. Combined with the ERP’s built-in artificial intelligence tools, this helps to eliminate one of the challenges poorly structured data poses, reducing the risk of unstructured data negatively affecting AI and automation outputs. 

While NetSuite offers a range of versatile tools by default, the client needed additional features tailored to its business, including ones related to FDA regulation and GMP. Our extensive knowledge and experience with NetSuite enabled us to develop modules that extended the functionality of the platform, addressing key compliance and quality control areas. By taking NetSuite’s existing capabilities and adding BDO’s Life Sciences Functionality, coupled with our team’s experience in the industry, we helped the client implement the solution to meet the regulatory standards in every geographic region where it has operations. This included FDA standards, such as GMP requirements — including 21 CFR Part 11 signatures — as well as European Medicines Agency GMP Annex 11 obligations. 

Lab employees with test tube
The Results

A Solution for Now and the Future 

  • Scalability

    The client’s recognition that they needed a scalable ERP with functionality that supports gene therapy companies allowed our team to proactively focus on their current state while providing them with a system that could evolve with their business. NetSuite’s scalability enabled the client’s small team to easily manage workloads within the system without being overwhelmed by an unnecessarily large platform. 

  • Source of Truth

    NetSuite’s structure provided clear parameters for data entry, promoting effective data governance practices by its very design. With BDO’s Life Sciences Solution, additional third-party app integration, and our team of knowledgeable NetSuite consultants, this created a single source of truth for GMP operations, regulatory inspections, and audits. 

  • Cost Effective Without Compromise 

    BDO’s NetSuite for Life Sciences delivered an affordable solution to the client while providing feature-rich tools, including the ability to add key functionality like manufacturing and supply chain models as they moved from the startup phase to commercialization. 

Is Your GMP System Ready for What’s Next?

Help ensure you’re fully aligned with GMP compliance requirements. BDO’s GMP Systems Readiness Assessment helps life sciences organizations identify gaps, mitigate risks, and prepare for audits with confidence.

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"NetSuite’s manufacturing and quality capabilities offered a strong foundation for the client’s operations, but BDO’s enhanced functionality was the catalyst that unlocked the platform’s potential to meet their compliance, data, and operational needs."
James Neal
Principal, NetSuite Practice Lead

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