Clients

Case Study 6
For a top ten, global pharmaceutical company

Challenge
Enable the retirement of a Xybion Path/Tox system and associated hardware, which had been in use at several global sites for over 15 years, including archival of pathology and toxicology system data. The archived data can be utilized for subsequent FDA submission and inclusion in a non-clinical GLP data warehouse.

Solution
  • Develop the tools, archival methodology and validation process needed to transform data from proprietary Xybion system extracts into XML. Permits future inclusion of the information in a data warehouse, facilitates FDA submission, and maintains the data in human readable form.
  • Transform a subset of extracted Xybion data into the Standard for Exchange of Nonclinical Data (SEND) domains for use in a proof of concept to investigate simplifying future submission processes; worked with SEND Consortium
  • Develop a single run transformation process to eliminate future system maintenance costs otherwise associated with placing the data in a database or other software product
  • Generalize the development tools and archival model for the solution for applicability to other Xybion installations as well as other nonclinical systems

Result
Pathology and toxicology data was transformed and archived to XML, enabling the company to decommission existing Xybion installations and associated hardware saving the company costly software maintenance fees and support costs related to outdated VAX systems. The SEND implementation was abandoned as the cost associated with cleaning years of data in order to convert it to the SEND format far outweighed the benefits of having the data in submission ready format.



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