R&D Data Management

 

A Fortune 500 medical device manufacturer needed an integrated system to support their product development and testing requirements. We developed a large temporal relational database and associated software. This system continues to support years of internal studies and FDA clinical trials and contains tens of millions of data points. 

 

Important features of the solution include:

  • Import and normalization of temporal medical device data
  • Data editing and scrubbing 
  • Data audit reporting
  • Rich graphical data visualization tools
  • Integration with clinical data management system (CDMS)
  • Integration with SAS clinical case report form (CRF) datasets
  • Data mart input generation
  • XML export to algorithm modeling and analysis system (Matlab)
  • Granular user security

In addition we developed a custom Excel toolkit to provide guided ad-hoc SQL querying  and data merging from the relational database and associated data mart as an easy means to provide input to sophisticated analysis spreadsheets. We also provided complete user and technical documentation and consulted on the deployment infrastructure.

 

This client/server system was developed using Microsoft SQL Server, Microsoft Reporting Services, (SSRS), Visual Basic, ChartFX graphing engine, SAS SDK, XML and Visual Basic for Applications. It utilizes over 80 database tables and views.

 

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