Streamlining Adverse Reaction Reporting: The OPeN System Revolutionizes Healthcare Communication






Improved Adverse Reaction Reporting




Brainit developed OPeN system together with SPAN d.d. The OPeN system is designed for both external and internal users. External users are healthcare professionals who will be able to register and log into the system, facilitate a simplified and faster reporting of side effects, track and review the status of their reports, and create templates for new side effect reports. Internal users are employees of HALMED (Croatian Agency for Medicinal Products and Medical Devices) who will expedite and streamline the entire process related to receiving reports of adverse reactions, recording them, updating, assessing, generating reports, and ultimately closing the reports.


The main objectives of the project are as follows:

  • Develop and establish two basic components of the OPeN system:
    • An external part for external system users (healthcare professionals) for reporting and tracking the status of suspected adverse reactions.
    • An internal part exclusively for HALMED employees to manage the life cycle of suspected adverse reactions.
  • Facilitate and expedite the reporting of suspected adverse reactions through the portal, smart PDF forms, XML files, or from connected HALMED systems (VigiFlow and Eudra Vigilance).
  • Standardize methods of reporting suspected adverse reactions.
  • Prevent the possibility of entering duplicate reports of suspected adverse reactions.
  • Allow updates and supplements to reports of suspected adverse reactions.
  • Enable communication between reporters and assessors of reports of suspected adverse reactions to obtain additional data.
  • Provide report generation according to user needs.
  • Establish medical terminology codebooks and enable their use.
  • Establish a database of suspected adverse reactions.
  • Integrate the OPeN system with existing systems in HALMED that contain information relevant to adverse reactions.

ScopeThe scope of the project is essentially defined as the development of an information system for electronic reporting and recording of adverse reactions. The project scope is divided into deliverables to be realized within the project. It is important to note what is outside the project scope but is essential to realize for the smooth use of the project results.

Tech stack

The OPeN system leverages a robust and efficient technology stack, combining the power of .NET and Angular frameworks to deliver a seamless user experience and reliable backend functionality.

.NET Framework:At the core of the OPeN system lies the .NET framework, renowned for its versatility and performance. .NET provides a solid foundation for building scalable, secure, and high-performance applications. With its extensive set of libraries and tools, developers can rapidly develop, deploy, and manage complex applications. The OPeN system benefits from the rich ecosystem of .NET, including the C# programming language, ASP.NET for web development, and Entity Framework for data access, ensuring the system's stability, security, and maintainability.

Angular Framework:On the frontend, the OPeN system harnesses the power of the Angular framework to deliver a dynamic and responsive user interface. Angular is a popular JavaScript framework maintained by Google, designed for building single-page web applications. With its component-based architecture and powerful features like two-way data binding and dependency injection, Angular enables developers to create interactive and intuitive user interfaces. The OPeN system utilizes Angular to provide users with a modern and engaging experience, facilitating seamless navigation, real-time updates, and efficient data manipulation.

Integration and Compatibility:By combining .NET and Angular, the OPeN system ensures compatibility across different platforms and devices, allowing users to access the system from various web browsers and devices. The modular architecture of Angular complements the robust backend capabilities of .NET, enabling smooth integration and interoperability between frontend and backend components. This synergy between .NET and Angular empowers developers to build and deploy feature-rich applications that meet the evolving needs of healthcare professionals and regulatory authorities.

In summary, the OPeN system leverages the .NET and Angular frameworks to deliver a comprehensive solution for adverse reaction reporting, providing users with a seamless and efficient experience while ensuring scalability, security, and compatibility.

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