Case Study: Biotech

BioElectron Corporation

Clinical Operations Tool

BioElectron was a clinical-stage platform biotechnology company that utilizes its extensive biochemical expertise to develop first-in-class treatments for genetic and acquired diseases. In order for them to undertake this potentially life-saving work effectively, they must be able to conduct, track, and effectively document clinical trials.

As these trials are governed by both HIPAA and FDA regulation, BioElectron assembled a team of computer scientists who were also subject matter experts. After two years of development, at roughly $2 million per year, they released the first version of a clinical trial management tool. Unfortunately, building such a tool was outside of the team’s core competency, and shortly after launch it became clear that the choice of underlying technologies (MSSQL and .NET) made the application difficult to support and maintain, and that the user experience was far from what BioElectron needed.

Fortunately we have experience working in a variety of regulatory environments, including not only HIPAA and FDA regulation, but also Sarbanes-Oxley and even DoD regulation, and could come alongside BioElectron to help them truly achieve their vision. We were able to leverage our regulatory experience, plus our suite of development tools and software development expertise, to build a new version of the application from scratch in only two months, complete with documentation, user manuals, and customer support.

We used a cloud-native architecture with a Go backend and React-js front-end to ensure portability and built the entire system as a set of deployable Docker containers to ensure testability, scalability, and availability. Given the sensitivity of the clinical trial process, we were careful to understand and support all of the complexities of the documentation and operational requirements imposed by the FDA. We also took the time to understand the needs of the users of the system, designing and intuitive and extensible workflow engine to boost productivity and reduce errors. Finally, we built a custom reporting engine that allowed the client to generate all of the documentation required for audits and certifications.