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 Logo

PointCross Logo

FOSTER CITY, Calif., July 20, 2022 (GLOBE NEWSWIRE) — PointCross Life Sciences announced today the full complement release of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules.

Used by 5 of the top 10 large pharma as part of the Xbiom™ regulatory suite, eDV is now available as a standalone tool in response to calls 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, users 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 user subscription and 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, including implementation of custom business rules

PointCross Life Sciences offers several types of configurations to deploy its eDV. Each of these configurations have very competitively priced, optional support, integration and validation services.

  1. Monthly subscription of eDV at an introductory rate of $170/month/user with volume discounts available for 3+ users and no annual contract requirement. A companion desktop tool is included to support offline clinical work-in-process data files. This is an ideal option for quick, 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 an integrated, qualified, validated workflow subject to their SOPs. APIs facilitate integrations for enterprise applications to access the 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, and easy comparisons of datasets across loaded versions. Users can generate Define files, TS.XPT, and easily convert XPT files to Excel (useful for the nonclinical user community spot-checking SEND datasets).

About PointCross Life Sciences

PointCross Life Sciences, founded in 2010 in the San Francisco Bay Area, is a privately held global technology company providing the Life Sciences industry with solutions in big data analytics, management, visualization, and warehousing. Powered by the Xbiom™ Insights and Regulatory platform, our offerings reduce risk and improve data quality, thus shortening time to market and generating better insights from both R&D and regulatory data for a globally dispersed number of CROs, large pharma, and small biotechnology Sponsors. For more information, please visit www.pointcross.com

Press Contact: 
Kunaal Madhavan
Marketing at PointCross Life Sciences

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