Clinical Data Standards Platform

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The upfront implementation of the data standards in a sponsor’s data management and statistical environment enables sponsors to automate the exchange of specifications and instructions to their internal and external partners.

A central data standards library and a metadata repository cannot only be used to generate study specifications, but will also enable the verification of the study data and metadata against the specifications.

Business & Decision Life Sciences supports its clients in the development and maintenance of such a Clinical Data Standards Platform.

Support can be provided for one or more of the platform elements below:

  • Creation of a Data Standards Library including an (e)CRF Library, CDASH/SDTM/ADaM Library and Therapeutic Area Library
  • Set-up of a Study Specification process by specifying the specifies the visit schedule and the needed (e)CRF templates and auto-populating a Study Metadata Repository
  • Development of a metadata repository to enable: 
    • Study build
    • Data model compliance checking
    • Define.xml generation
    • Conversion automation
  • Implementation of a metadata extraction program to provide Study Metadata Specifications (e.g. define.xml CRT-DDS format) to partners
  • Solution to manage and measure conformance to your standards across partners and projects 
    • Comparison against Study Specifications
    • Validation against the Data Standards Library
  • Generation of pooled analysis based on CDISC data (ISS and ISE)
  • Creation of macros for ADaM dataset creation

Benefits

  • Data Standards Library facilitates  building Study Metadata

  • Reduces study Specification cycle times

  • Automation  of comparison and validation process

  • Increases consistencies across compounds

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