Creation OF ADaM, Define.xml v2.0 validation


Life sciences



The customer is a global Biopharmaceutical company and one of the largest  harmaceutical companies by both market capitalization and sales with $40 Billion annual turnovers and global footprints in 140 countries. The company is committed to deliver innovative health solutions.


  • Non-Availability of tools to examine the complete array of checks for validating the contents of Define.xml
  • Automation Process was not feasible as XML Map software was being used to get all the metadata into SAS datasets in required format
  • It was a daunting task to accommodate all these measures
  • Frequent use of services from an external specialist for any Ad-hoc request that emerged when the metadata evolved during the trial


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Eliminated extra steps used in XML Map and other external software in Define.xml validation process and the manual steps that followed for formatting the metadata dataset

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Process automation was made possible for an end-to-end solution

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Augmented the ability to extract different parts of Define.xml metadata for selective validation needs

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Built an in-house Define.xml validation process which offers more than what other external software can provide, getting rid of the need to depend on the services of a specialist in Define.xml