Global Medical Safety

Global Medical Safety


Our client is a multinational Fortune 500 pharmaceutical company aimed 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 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 performance of employees, does not prevent human errors and 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 few tools to automate legacy data migration and application supporting business process for one of the customer’s teams. Application was developed using .NET platform and Telerik UI for Silverlight. Using Silverlight and WCF RIA Services allowed customer to get rich user interface logic at the client side and logic of business processes at the server side along with simple deployment model, network fault tolerance and concurrent data update issues handling developed fast.

The implemented application has a rich set of features simplifying daily tasks of the customer teams performed in a user-friendly environment. As a result, it became a system which allows to implement and incorporate application supporting different business processes handled around PV area by our customer teams.

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.
  • And more customer teams are joining this system today and want their business processes to run within it…

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


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


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