Clinical Resources

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Universal Data Model – PhUSE Americas Winter SDE

We presented a paper at the PHUSE 2022 Americas Winter Single Day Event on the topic of Universal Data Model (UDM) being leveraged to streamline pathways to SDTM and ADaM Standards.  This paper introduces Xbiom to automatically map raw data to SDTMs. SDTM Automation By Reusability and Repeatability Leverage a Universal Data Model (UDM) to Streamline...

eDataValidator for SDTM, ADaM & SEND

View Webinar Recording: eDataValidator (eDV) for Validating SDTM, ADaM & SEND Click here to sign up for eDataValidator Having trouble viewing the video? Please click here Here is a brief overview of the webinar's key highlights and takeaways.  In this webinar, we provided a 30-minute walkthrough of eDV, demonstrating how users can effectively validate their SDTM, ADaM or...

Phuse US Connect 2024

Date: February 25–28 , 2024 Bethesda, Maryland, USA PointCross will be represented at PHUSE CONNECT by: Rahul Madhavan, Vice President, Strategic Programs Harinarayan Gopichandran, Vice President Technical Solutions Sunil Gupta, Executive Consultant Learn more: PHUSE US Connect 2024 

SCOPE Summit for Clinical Ops Executives 2024

Date: February 11-14, 2024 Rosen Shingle Creek Orlando, FL PointCross will be at SCOPE Summit for Clinical Ops Executives 2024 in Orlando, FL, from February 11-14. Our Vice President Rahul Madhavan (Strategic Programs) and Vice President Harinarayan Gopichandran (Technical Solutions) look forward to meeting our customers on site and forming new relationships with those interested in...

PHUSE SDE 2023

Progress Towards CDISC 360 Mission with CDISC Standards, Metadata Design, SDTM/ADaM Automation and Compliance   Date: Thursday 10 August 2023Location: Wind Room, Foster City Community Center, 1000 E Hillsdale Blvd, Foster City, CA 94404 Director & the SDE Chairs: PHUSE SDE 2023 Director & the SDE Chairs PHUSE August Single Day Event (SDE) on Thursday, August 10th. This conference,...

Bayer Data Insights Event Berlin

Bayer held an internal “invitee only” day to discuss, celebrate, and share the possibilities and use cases of PORTIN – a portal for translational data integration. PORTIN is built on PointCross Xbiom with integration to various enterprise data ...

10 Most Recommended Pharma & Life Sciences Technology Companies – 2023

PointCross Life Sciences has been recognized as one of the "10 Most Recommended Pharma & Life Sciences Technology Companies - 2023" by CIO Insider India Our Chief Architect, Raja, plays a pivotal role in our commitment to data transformation, security, and innovation. Learn more about our flagship product, Xbiom, designed for today's drug discovery landscape,...

PointCross Incorporates PMDA Validation Rules V4

On February 28th, 2023, PMDA released a new validation rule version 4.0 for SDTM (Study Data Tabulation Model) and Define.XML. A major change in PMDA Validator Rules v4.0 is the support of SDTM IG v3.3, as well as the removal of support of Define.xml 1.0 PointCross Life Sciences has incorporated the updated rulesets on April 28th, 2023....

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

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...

Beginning on September 15, 2021, FDA will begin enforcing the Technical Rejection Criteria (TRC).

FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 ( Technical Rejection Criteria for Study Data) The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Any electronic submission submitted after Sept 15th,...

SEND DART is now supported by PointCross Life Sciences

Support for SEND DART IG 1.1 as per FDA Data Standards Catalog Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog ( FDA Announcement; FDA Data Standards Catalog) Our Software solution (Xbiom) and services are set up to accommodate DART IG 1.1, and we have been generating SEND datasets for DART studies including...

CIMS™: Clinical Data Repository for SDTM Data & Beyond

Clinical Data Repository for SDTM data fills an urgent gap CIMS™, the PointCross Life Science built Repository for Clinical SDTM Data is now available to Pharma sponsors with compliant standardized NDA submissions to FDA guidance. Silver Spring, MD, March 14, 2016 PointCross Life Sciences today announced its formal release of CIMS™, a Hadoop (HDFS) based extensible repository....

PointCross and InterpretOmics partner for Clinical and Genomic Biomarker Management for Drug Development

Foster City, CA, April 20, 2015 /PRNewswire/ — PointCross Life Sciences today announced a strategic partnership with InterpretOmics Pvt. Ltd. to provide an integrated Big Data and globally accessible environment for genomic interpretation and analysis of all biomarkers collected in the context of clinical trials and nonclinical studies. This platform will serve the needs...