PointCross releases eDataValidator for SDTM, ADaM, SEND, and Define.XML conformance to prevailing FDA, CDISC, and PMDA rules

Integrated QC dashboard and unlimited validation cycles for interim and final datasets creates industry’s most user-friendly validator

PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules.

In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing demand from sponsor Clinical Operations, biostatisticians and biometrics communities. Industry called for easily accessible, cheaper tools that work well for qualified workflows for data standardization to SDTM, and analysis datasets in ADaM in incremental stages until the final packaging for submission.

eDV offers limitless validation of Clinical SDTM as well as Nonclinical SEND, making this a single solution for IND, NDA and BLA preparation.

With eDataValidator, you can:

  • Validate an unlimited number of interim or final datasets
  • Work with a variety of data formats including CSV, XPT, SAS7BDAT, or Excel
  • Save costs with a $170 monthly subscription; no annual contract requirement
  • Integrate eDV leveraging its APIs into various enterprise dataset generation scripts used by your biometrics teams as part of their SOP.

Depending on whether you represent a Sponsor or Contracted Biometrics team – we have a right-sized configuration for you. Each of these configurations have very competitively priced, optional support, integration and validation services from PointCross.

  1. Monthly subscription of eDV hosted by PointCross on the cloud, at an introductory rate of $170/month/user with volume discounts available for 3+ users and no annual contract requirement. To support the need to work privately with sensitive clinical work-in-process data files, a companion desktop tool is included. This is an ideal option for quick and inexpensive on/off ramp use by organizations working on specific trial or study data.
  2. On-Premise installations of eDataValidator for organizations committed to having a integrated, qualified, validated workflow subject to their SOPs. The integration is facilitated by APIs that allow enterprise applications to access the various data validation and quality checking capabilities in eDV.

eDataValidator simplifies the validation experience, with a built in QC dashboard to review and verify reported issues/non-conformities, easy comparisons of datasets across loaded versions, with generation of Define files, TS.XPT, and easy conversion of XPT files to Excel (useful for the nonclinical user community spot-checking SEND datasets).

We invite you to evaluate eDataValidator risk free for a no-cost, 30-day trial. Ask us about how we can help incorporate eDataValidator into your qualified, validated SOPs for your regulatory submission dataset requirements.

Full press release can be found here

For all inquiries regarding eDataValidator, contact:
PointCross Life Sciences
edvsupport@pointcross.com