All Resources

Clinical Nonclinical

Clinical Whitepapers

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...

Nonclinical Whitepapers

Clinical Webinars / Demos

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...

Nonclinical Webinars / Demos

Webinar on The Most Common Issues in Preparing SEND: Explained

Join us for an exclusive webinar on May 29th, 2024, 12 PM EST/9 AM PST where PointCross will talk about The Most Common Issues in SEND!  Learn how SEND-ASSURE ensures consistency with the audited Study Report, conformance to Technical Rejection Criteria guidelines, and follows details of the Technical Conformance Guide as the trusted references for...

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...

Preparing for Nonclinical eData Submissions – ‘SEND’ & Beyond

Preparing for Nonclinical eData Regulatory Submissions to the US FDA-“SEND” and Beyond Presenters: Shree Nath, PhD, Vice President, PointCross Life Sciences Timothy J. Kropp, PhD, Team Leader, Tools Technology and Innovation Team, US Food and Drug Administration The recording of this webinar is no longer available from the American College of Toxicology but the presentation slides are available...

What does SEND Readiness mean for your company? – Webinar

Watch the replay of this webinar held on June 27: What does SEND Readiness mean for your company The FDA will soon require drug companies to transmit their nonclinical data submissions in standardized electronic formats like SEND. This will fundamentally impact workflows and data management within drug companies and CROs, and will require nonclinical toxicologists to...

Guarding Your Drug Safety Blind Spots

Hosted Webinar: DSEC Panel Discussion: Search, Analytics and SEND: Guarding Your Drug Safety Blind Spots Sponsored by PointCross Life Sciences The FDA has announced its intent to mandate nonclinical data submissions in standardized formats like SEND. Consequently, Agency reviewers expect to be spending more time on data analysis and detection of potential safety signals across studies....

Clinical Conferences

PointCross attends Verisian’s first community event in Hyderabad

We're thrilled to share that our team members, Raja Ramesh and Arpitha, recently had the privilege to attend Verisian's first community event in Hyderabad. During the event, we had the opportunity to present on: "Leveraging LLMs for Traceable Metadata Specifications and Executable Search Expressions in TFL & ADaM Generation." For those who couldn't make it, fret...

SOT ToxExpo 2024

PointCross was present at the 2024 SOT #ToxExpo. Date: March 10–14, 2024 Salt Palace Convention Center in downtown Salt Lake City, Utah Takeaways: CROs and Sponsors love PointCross’ instant SEND quote generator, fast turnaround time, and study data visualization offering Integrating bioanalytical and complex biomarker data with as collected in-life data can be done in real time and people loved seeing subject level study details for ongoing...

PHUSE US CONNECT 2024: PointCross Highlights Rapid SDTM and Compliance Dashboards

PointCross Life Sciences was thrilled by the level of interest and excitement with regards to the poster we presented at PhUSE Connect 2024, titled “Rapid SDTM and Compliance Dashboards”. We had some important dialogue with industry peers and leaders in the space pertaining to revolutionizing SDTM development in clinical research. Key Takeaways: Integration of Standards and...

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 ...

Nonclinical Conferences

SOT ToxExpo 2024

PointCross was present at the 2024 SOT #ToxExpo. Date: March 10–14, 2024 Salt Palace Convention Center in downtown Salt Lake City, Utah Takeaways: CROs and Sponsors love PointCross’ instant SEND quote generator, fast turnaround time, and study data visualization offering Integrating bioanalytical and complex biomarker data with as collected in-life data can be done in real time and people loved seeing subject level study details for ongoing...

PHUSE US CONNECT 2024: PointCross Highlights Rapid SDTM and Compliance Dashboards

PointCross Life Sciences was thrilled by the level of interest and excitement with regards to the poster we presented at PhUSE Connect 2024, titled “Rapid SDTM and Compliance Dashboards”. We had some important dialogue with industry peers and leaders in the space pertaining to revolutionizing SDTM development in clinical research. Key Takeaways: Integration of Standards and...

PhUSE CSS 2020 Poster

PointCross presented and was awarded Best Poster In the Industry category for our poster, A Process for Automated Reconciliation of SEND Datasets with Study Reports for Confident Submission and Review.

Clinical News

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...

Nonclinical News

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,...

FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021

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,...

PointCross Life Sciences and Xybion forge strategic partnership to deliver SEND services to assure FDA review ready submissions

XYBION AND POINTCROSS ESTABLISH A STRATEGIC PARTNERSHIP TO DELIVER SEND SERVICES TO ASSURE FDA REVIEW READY SUBMISSIONS March 11, 2016: PointCross Life Sciences and Xybion announced today a strategic partnership to provide the Biopharma industry with a complete suite of data management, standards governance, data quality assurance and regulatory review solutions to comply with the FDA’s...

PointCross Life Sciences and Smithers Avanza forge strategic partnership for SEND solutions

For biopharma companies, this collaboration will streamline the flow of high quality CDISC SEND standardized data for regulatory submissions required by the FDA and to serve sponsor R&D needs Silver Spring, MD, November 9th, 2015 PointCross Life Sciences and Smithers Avanza announced today that they have entered into a partnership to provide SEND solutions to their Toxicology Services clients....

PointCross & CAC EXICARE Partner for CDISC Implementation

PointCross Life Sciences and CAC EXICARE forge strategic implementation plan For pharma and biotech companies in Japan, this collaboration will ease the implementation of CDISC standards for electronic regulatory submissions which are a requirement by both the US FDA and Japanese PMDA CAC EXICARE’s Location in Tokyo Japan and PointCross Life Sciences’s Location in Foster City,...

PointCross offers FDA eData SaaS lifecycle on cloud

PointCross announces SaaS offerings on the cloud to span the entire lifecycle of eData submissions to FDA Nonclinical Study Data Specification(NSDS) for the definition of a study before it begins, and ToxVision-as-a-software-Service to review studies after they are completed using the same visualization and analysis tools as in FDA’s NIMS are now available as a software subscription. Silver...

NIMS v2.5 for SEND released to FDA, Industry access

NIMS Version 2.5 for SEND released to the FDA, Now Available for Industry NIMS enables faster, deeper and more insightful regulatory review of nonclinical study data for safety signal detection and analysis Silver Spring, MD, March 12, 2015/ PRNewswire PointCross Life Sciences today announced that the FDA has accepted NIMS version 2.5 for operational use to review...

SEND-ASSURE ensures FDA submission data consistency

PointCross announces SEND ASSURE for Data Consistency in Submissions to the FDA SEND-ASSURE is an audit solution to reduce risks in Regulatory e-Data Submissions Silver Spring, MD, March 9, 2015/ PRNewswire PointCross Life Sciences today announced the launch of its SEND-ASSURE audit solution to help pharmaceutical companies avoid the consequences of submitting standardized nonclinical data that is...

FDA awards IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats

FDA awards $20M IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats   FOSTER CITY, Calif., Sept. 26, 2013 /PRNewswire PointCross Life Sciences, Inc. announced that it has been awarded an IDIQ contract with a cap of $20 Million by the U.S. Food and Drug Administration...

PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions

FOSTER CITY, CA, June 6, 2013 PRNewswire PointCross Life Sciences today announced the immediate availability of a multi-tenant software as a service (SaaS) environment to support the preparation and review of study datasets prior to their submission to the FDA’s NIMS (Nonclinical Information Management System) solution. These study data sets are not limited to the...

PointCross Life Sciences: Gartner Cool Vendor 2013

PointCross Life Sciences Named to Gartner’s Cool Vendor 2013 List for Life Sciences FOSTER CITY, CA, May 15, 2013 PointCross Life Sciences announced today that it has been included in the list of “Cool Vendors in Life Sciences, 2013” ¹ by Gartner, Inc. PointCross Life Sciences is a leading provider of solutions designed to unleash the...

PointCross Life Sciences’ SENDBox and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA’s Upcoming e-Data Submission Mandate

Press Releases PointCross Life Sciences’ SEND Box and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA’s Upcoming e-Data Submission Mandate FOSTER CITY, CA, March 11, 2013 PRNewswire As a result of PDUFA V, the FDA will soon require Biopharma companies to submit their nonclinical study data in standardized electronic formats such as CDISC SEND, the Standard...

PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services

Press Releases PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services FOSTER CITY, Calif., Oct. 3, 2011 PRNewswire PointCross Life Sciences, Inc. has announced that it has been awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract by the U.S. Food and Drug Administration to provide an integrated off-the-shelf software environment comprising of...