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 customer 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 does not meet present requirements as it slows down employee performance, does not prevent human errors; besides, there is a lot of duplication due to a lack of data integration.

The first goal was to analyze existing data and design Oracle database storage so that it can capture all the data needed. As the second part, we developed several tools to automate legacy data migration and an application supporting business process for one of the customer’s teams. The application was developed using .NET platform and Telerik UI for Silverlight. Using Silverlight and WCF RIA Services allowed the customer to implement a rich UI at the client side and business process logic at the server side, along with a simple deployment model, network fault tolerance and concurrent data update issues handling.

The implemented application has a rich set of features simplifying customer teams’ daily tasks and performing in a user-friendly environment. As a result, the system now allows implementing and incorporating applications supporting different 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, more customer teams join the system and want their business processes to run within it.

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.

GMS development allowed the customer’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 customer’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.