Global Medical Safety

Our client is a multinational Fortune 500 pharmaceutical company aiming to provide products and services of the best quality to the customers along with high responsibility standards to the patients and to all who use its products.

The client has multiple teams with hundreds of people in total, which are involved in pharmacovigilance (PV) process across the globe. Since each team is responsible for its own part of the process, historically most of the process data capture was done using a simple set of tools like Excel spreadsheets, Access databases, Word documents, each team having its own set of files. This toolset did not meet present requirements as it slowed down employee performance, did not prevent human errors; besides, there was a lot of duplication due to lack of data integration.

The initial goal of the project was to analyze existing data and design a database storage model capable of capturing all required information. As the second part of the initiative, several tools were developed to automate legacy data migration, along with an application supporting business processes for one of the client’s teams.

The GMS application has since evolved into a modern web-based solution built on .NET 8 and C#, with Entity Framework Core providing the data access layer and PostgreSQL serving as the primary database. The user interface is implemented using Angular 19 with HTML/CSS, providing a modern, responsive, and maintainable web experience. The microservice-based architecture enables independent development and deployment of system components, supports scalability, and facilitates integration with other services, including AI-enabled tools such as Co-create.

The application provides a rich set of features that simplify the daily activities of the client teams in a user-friendly environment. The platform is designed to support the implementation and integration of applications covering different pharmacovigilance (PV) business processes.

In particular, the following business processes are implemented within the GMS system:

• adverse event reporting compliance tracking application
• Individual Case Safety Reports (ICSR) quality checking application
• aggregate reporting process support application
• common data management application
• various metrics configuration and capturing application.

Currently, the platform is continuously enhanced and modernized, introducing new capabilities and adopting leading technologies and industry best practices.

GMS is a US Federal Drug Administration validated application. It is developed in accordance with GxP guidelines by a distributed customer project team running other system parts, such as ETL and Data Reporting, using Agile methodologies.

Today multiple client teams actively use GMS to support their business processes, benefiting from its capabilities and user-friendly experience.

GMS development allowed the client’s employees to increase productivity and concentrate on real business process tasks instead of spending time on data quality issues. Successful project implementation allows other client’s PV teams to incorporate their business processes into GMS and to use all its services, such as access management, user-friendly interface with data and business rules validation, centralized data storage, concurrent data update issues resolution within an FDA validated application.