eDataValidator

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Please reach us at edatavalidator@pointcross.com to learn more about the eDataValidator. 

Video tutorial on eDataValidator can be found here

eDataValidator from PointCross Life Sciences Inc., a wholly owned subsidiary of PointCross Inc. is a powerful and comprehensive validation tool for all clinical and nonclinical study submission datasets to the FDA or PMDA. It is built to support:

  1. Data preparers – both SDTM and ADaM for Clinical; as well as SEND dataset for Nonclinical studies. It provides tools and report that will guide the preparers from a raw starting point to a proper, compliantly formatted data set with selected controlled terminology as collected data is available and merged to form the final submittable set.
  2. Quality and Regulatory Affairs – from both Clinical and Nonclinical - who wish to follow their internal SOPs and sign off on the submissions and the associated Reviewer’s guides and Define.XML files with clarity on all the conformance rules of CDISC, all the business rules of FDA, and validator rules published by FDA or PMDA that cover SDTM, ADaM, SEND and Define.xml.

Availability of eDataValidator:

The eDataValidator is available in three (3) possible ways!

  1. For Data preparers, simply download a desktop version, which is provided freely for now, from http://info.pointcrosslifesciences.com/edatavalidatordownload
    Two videos on how to use it is available at eDataValidator Videos. The desktop version is covered in the Desktop eDataValidator Video. This version is local to your machine and you data never leaves your desktop or laptop. It is meant for data preparers who are not working in a shared and controlled data environment under a SOP.
  2. For formal use of the validator with collaborative work with other members of the team in a web-delivered environment the AWS (Amazon Cloud Services) hosted version is ideal. There is a attractively priced subscription and it is directly available from the Amazon AWS market place especially if your organization has a Amazon account. The web version is demonstrated in the eDataValidator Web Hosted Version.
  3. A dedicated or SIMT (Single Instance Multi-Tenant) hosted environment is also available with a direct negotiated contract with PointCross Inc. The capabilities are identical to those available to the AWS hosted eDataValidator solution users.
    Features:
  • Drag & Drop or select files, including .zip files for validation easily
  • Select from a range of validation rules from:
            - CDISC SDTM, ADaM, SEND and their specific IG Versions
            - PMDA – published rules and their version
            - XML (published by PMDA)
            - CDISC Controlled Terminology versions (by date of release)
            - Other special rules sets including PointCross recommended rules for best practice
  • Apply an entire rule set, or some of the rules in the set, to support data preparers during work-in-process
  • Use the interactive QC Dashboard to dynamically diagnose data issues that need to be corrected or attended to before finalizing
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  • Automatically generate validation reports in .CSV, .XPT, SAS7BDAT, Excel formats
  • Validation automatically respects the selected IGs and Controlled Terminology version stated in the TS.XPT files of the study

    eDataValidator2
  • Separate, and cogent reports that are specific for each type of report selected. Reports are automatically organized in the user’s workspace for ease of user experience
  • Allows baselines – users developing the submittable data sets can set up a baseline for their data sets and compare the progress of the subsequent data sets against the base lines for control and definite progress towards completion.

For more information on the eDataValidator, please contact us at edatavalidator@pointcross.com.