How Health Decisions transformed their clinical trial process

About

Health decisions is a clinical trial management company that provides its services for running and maintaining clinical trials. Despite being in business for some time, the company found that the third-party software solutions they were using were not meeting their specific needs and were also quite costly. In response, Health Decisions made the strategic decision to develop its own software solution, aimed at better fulfilling their requirements for clinical trial management. This move could potentially lead to increased efficiency, reduced costs, and an overall improvement in the quality of services provided by Health Decisions.

Challenge

Divectors was tasked with creating a single-tenant solution capable of simultaneously managing multiple studies. The primary challenge of the project was to ensure that the electronic data records were kept secure and isolated, while also providing support for multiple study environments in which changes to the study could be developed, tested, and approved. Additionally, it was necessary to create a highly configurable study structure that could be updated in response to collected data. Meeting these requirements was critical to the success of the project.

Solution

Our team utilized the .NET technology stack to design the system, which includes a web application and various services dedicated to database and data management. One of the notable features we developed was a dynamic language runtime (DLR) that enables users to write custom equations within the system, manipulate data, and modify the structure of a trial based on entered data.

To ensure high levels of security and data isolation, the system is composed of multiple databases, with each study having its own dedicated database, and even different stages/environments of the same study having separate databases. Additionally, the system is compliant with HIPAA regulations, ensuring that patient data remains confidential and protected.

Results

Our client has achieved significant success in running multiple studies using their custom-built platform, which perfectly caters to their unique requirements. The costs they incurred during the development of this platform have already proven to be more economical than the expenses of using third-party software over the last several years.

The platform is designed to enable the trial configuration and settings to be modified and verified in isolated environments before being applied to the production environment, without affecting the integrity of patients' data. Moreover, the system automatically updates previously entered data to correspond to the new configuration.

To further streamline the process, all of the trial's infrastructure requirements are generated and managed automatically, including the creation of new trials. Overall, the platform has been a resounding success, providing our client with a cost-effective, streamlined, and efficient solution for running their clinical trials.