Next Generation. Extensible And Truly Global Platform.

Globally Accessible and Easy to Maintain

Client: Leading Clinical Research Organization

Situation

The current desktop based systems was built using technology which was becoming increasingly difficult to maintain, used tightly coupled component architecture which requires huge amounts of FDA revalidation effort in case of enhancements to the system and does not support globally distributed studies.

Engagement Scope

  • Redevelop application using latest Microsoft technology
  • Reduce ongoing 21 CFR Part 11 re-validation effort required for each new enhancement to the system
  • Support multi-location and global studies
  • Retain the key test algorithms and their IP

Technology & Methodology

  • Dotnet 4.0, WPF, Web Services
  • Silverlight, Asp.Net, Ajax
  • Enterprise Library
  • LINQ, SQL Server 2008
  • MSMQ, IPC
  • XNA 4.0

Benefits Delivered

  • 21 CFR Part 11 compliant system and documentation
  • Considerable cost savings in ongoing FDA system revalidation by using highly componentized architecture
  • New globally accessible system
Next Generation. Extensible And Truly Global Platform.

“A complex re-write delivered well.”

Associate Director,
Leading Clinical Research Organization