# PointCross Life Sciences

> PointCross Life Sciences is a Foster City, California software and services company that turns the messy data of drug development into FDA-ready submissions. Through its XBIOM platform and eDataValidator, it standardizes nonclinical and clinical study data to CDISC SEND, SDTM and ADaM formats, runs a Hadoop-based data repository for sponsors, and supplies the U.S. FDA itself with the software reviewers use to read nonclinical submissions. The company quietly powers roughly a quarter of all FDA SEND submissions.

- **Founded:** 2007
- **Headquarters:** Foster City, California, United States
- **Founders:** Suresh Madhavan (Founder & CEO)
- **Team size:** ~190-216 employees across the US, India and Europe
- **Products:** XBIOM Platform, XBIOM Insights, eDataValidator (eDV), CIMS, Single-Track Processing
- **Notable:** Named to Gartner's 2013 Cool Vendor List for Life Sciences, Powers approximately 25% of FDA SEND submissions, Processed 10,000+ studies with a reported zero technical rejections

## Products & services

- **XBIOM Platform** — End-to-end study data platform spanning ingestion (VDR), metadata repository (MDR), a unified data model repository, automated regulatory submission generation, and nonclinical and clinical analytics/visualization modules.
- **XBIOM Insights** — Big data platform that semantically integrates clinical data, biomarker data, bio-sample availability and bioinformatics registry data so researchers can stratify cohorts and correlate findings against biomarkers in minutes - aimed at oncology, immunology, CNS and CV precision medicine.
- **eDataValidator (eDV)** — Validation software for SDTM, ADaM, SEND and Define.XML data, checking conformance to FDA, CDISC and PMDA rules in a single tool for IND, NDA and BLA preparation.
- **CIMS** — Hadoop (HDFS) based, extensible clinical data repository for SDTM data with built-in workflows, validation and packaging for eCTD M5 submissions.
- **Single-Track Processing** — Service delivering validated, submission-ready SEND datasets and study reports for toxicology and safety studies in 2-3 weeks with real-time monitoring.
- **SEND & SDTM Services** — Dataset preparation, QC, automated SDTM/ADaM generation, legacy data digitization, and regulatory data review services.

## Achievements

- Named to Gartner's 2013 Cool Vendor List for Life Sciences
- Powers approximately 25% of FDA SEND submissions
- Processed 10,000+ studies with a reported zero technical rejections
- Awarded an FDA IDIQ contract to supply the nonclinical study data review environment
- Serves 5 of the top 15 pharmaceutical companies

## Latest updates

- **2017-02** — Launched XBIOM Insights clinical biomarker platform for precision medicine and signed two deals coming out of stealth.
- **2017-01** — Partnered with Xybion to deliver SEND services for FDA review-ready submissions.
- **2016-04** — Announced CIMS, a Hadoop-based clinical data repository for SDTM data.

## Links

- Website: https://pointcrosslifesciences.com
- LinkedIn: http://www.linkedin.com/company/pointcrosslifesciences
- Twitter/X: https://twitter.com/PointCross_LS
- Facebook: https://facebook.com/Pointcross-Life-Sciences-484062895006542/

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Profile page: https://yespress.io/pointcross-life-sciences
Published by YesPress — https://yespress.io
Last updated: 2026-06-20