Clinical Whitepapers
PHUSE US Connect 2025
Date: March 16-19, 2025Location: Orlando, Florida PointCross Life Sciences participated in PHUSE US Connect 2025 in Orlando, where Harinarayan Gopichandran presented his paper, “SD03: Turbocharge Your Trials: Transform CRF Creation and the CDISC Standardization Process with Smart Metadata Repositories and AI/ML Innovations.” Key highlights included demonstrating how our MDR:• Enhances data standardization for SDTM and ADaM...
From FAIR Data to FAIR Knowledge Sharing
Phuse poster jointly worked with PointCross Lifesciences and Roche
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...
Xbiom Accelerating Innovation in BioPharma
Whitepaper
Unified Machine Readable Target Data Models from Smart Transformer of Disparate Biopharma Source Data
Whitepaper - June 20, 2019
Xbiom: Translational & Biomarker Research Workbench
2 Page Brochure
Smart Transformer of Clinical & Nonclinical Data for Insights
PhUSE US Connect - February 2019
Xbiom: Biomarker Workbench for BioTech & Pharma
This draft white paper from PointCross Life Sciences Inc. (Foster City, CA) presents the opportunities for biomarker and biologics based therapeutic development using search analytics and data integration of clinical and biomarker data as available in its Xbiom solution
PhUSE paper- Ensuring consistency of SEND Datasets with Study Reports using Machine Learning Algorithms
PhUSE paper- Ensuring consistency of SEND Datasets with Study Reports using Machine Learning Algorithms
Ensuring consistency of SEND Datasets
PhUSE CSS March Poster_Ensuring consistency of SEND Datasets with Study Reports using Machine Learning Algorithms
Standards and Ontology Driven Workflow Automation of Clinical Studies
Standards and Ontology Driven Workflow Automation of Clinical Studies - PointCross Life Sciences
Xbiom™: Precision Medicine Biomarker Research
There is a perfect storm brewing where advances in genomic screening, identifying molecular biomarkers and precisely targeted medicines and diagnostics, smart monitoring of patient vitals and physiology using devices such as smart phones and...
Nonclinical Whitepapers
From FAIR Data to FAIR Knowledge Sharing
Phuse poster jointly worked with PointCross Lifesciences and Roche
Xbiom– A Workbench for Biomarker & Translational Research
The paper presents query masks for stratifying cohorts and search analytics on clinical and biomarker data as available on the Xbiom solution
Benchmark Your SEND Readiness Whitepapers
Benchmark Your SEND Readiness
Synthetic Dataset
Synthetic Dataset for Public Use (PC201708)
SEND ASSURE™ Whitepaper
Assuring your SEND Datasets are Consistent with your Study Report...
Data Standardization Services
Receive a SEND package guaranteed to load into the FDA's Nonclinical Portal...
Data Consistency and Quality Issues in SEND Datasets
PointCross has reviewed numerous SEND datasets prepared for test submissions to the FDA and has worked with the FDA on their KickStart program to ensure that received datasets are suitable for pharm/tox review...
Importance of Data Consistency and Quality in SEND Submissions
With the recent release of the FDA’s binding guidance for electronic submission of nonclinical data, sponsor submissions will be required to include electronic datasets in SEND format in addition to the study report...
Semantic Data Exchange for Pharma R&D
Semantic Data Exchange Facilities to enable flexible support for data standards and cross-study meta analysis in the Pharmaceutical Industry...
Clinical Webinars / Demos
Webinar- Automating Biomarker Standardization: Highlighting best practices for the Cell Phenotyping (CP) domain
Webinar Overview: Date: Wednesday, April 23rd, 2025Time: 09:00 AM PT Biomarker standardization is crucial for regulatory-compliant clinical trials and drug development. This webinar will explore how intelligent automation enhances biomarker data quality, streamlines regulatory submission, and improves patient outcomes. Key Takeaways:• Standardizing biomarker data for compliant submissions• Automating cell phenotype characterization using marker expression• Addressing standardization challenges...
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...
Webinar on Harmonizing Raw Data with CDISC Standards to Streamline SDTMs
Date: Thursday, January 19, 2023 Time: 09:00am PT / 12:00pm ET
Enabling Data Integration for Translational & Precision Medicine
Webinar Recording May 2021
Xbiom Workbench and Insights
Data Hub for Clinical, Translational and Biomarker Research- View Video
Xbiom Smart Transformer – Demo
Rapidly map legacy and raw data to CDISC standards - View Video
Integrating Clinical, Biomarker & Disparate Data
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
Nonclinical Webinars / Demos
Webinar: Ensuring 100% Submission Data Quality with SEND ASSURE
Date: Wednesday, May 28, 2025 Time: 9:00 AM PT | 12:00 PM ET Most SEND preparers (CROs, Vendors, In-house) perform spot-checks, visual QC, or checklist based compliance to ensure their SEND datasets are submission ready and compliant with the FDA's Technical Conformance Guide and Technical Rejection Criteria. Learn how PointCross uses automation, reconciliation checks, and 100% traceability...
Unlocking Insights: Cross-Study Analysis of SEND Datasets with Xbiom™
For those who couldn't join us live, we're excited to share the recording of our third SEND webinar! This session focused on Cross-Study Analysis of SEND Datasets using Xbiom™, where we covered everything from building a solid study repository to comparing datasets from similar compounds and classes. During this webinar session, you will learn: Why you...
Webinar on Visualization of SEND datasets
Date: Wednesday, July 31st, 2024Time: 09:00 AM PT / 12:00 PM ET PointCross Life Sciences held a webinar on Visualizing your SEND datasets. What we covered: How to visualize SEND datasets for QC Conducting in-depth subject-level reviews Mastering cross-study comparison and analysis Understanding the limitations of using only SEND datasets for visualizations Exploring pre-templated and customized TFLs This session is tailored for professionals in...
Webinar on The Most Common Issues in Preparing SEND: Explained
In this webinar, we discussed 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 data submission and regulatory compliance. Key Takeaways: The most common errors in SEND with recommendations to correct them Feedback related to submission and analysis Pinpoint QC ideas Submit...
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...
Interim Study Monitoring Webinar
October 19th 2021
Xbiom Smart Transformer – Demo
Rapidly map legacy and raw data to CDISC standards - View Video
SEND Dataset FRR Webinar: Tools & QC Checks
June 8th, 2020
100% Consistency Check of SEND Datasets Against NCSR
March 17th, 2020
PointCross Live Discussion – Recent Regulatory and Standards Updates
Recent FDA Regulatory and Standards UpdatesTuesday, December 11th, 2018
Integrating Clinical, Biomarker & Disparate Data
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
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...
Clinical Conferences
PointCross at PHUSE SDE 2025 – South San Francisco
Date: Friday, 22 August 2025Location: Genentech, 350 DNA Way, South San Francisco, CA 94080 Event Theme: Revolutionising Healthcare: The Transformative Power of Data Analytics and AI The PHUSE SDE 2025 will bring together experts from healthcare, technology, and regulatory sectors to discuss how advanced analytics, machine learning, and predictive modelling are transforming healthcare and drug development....
PointCross Life Sciences is a Ruby Sponsor of CDISC India Day 2025
PointCross Life Sciences was proud to participate in CDISC India Day 2025, hosted by Eli Lilly in Bengaluru. The one-day event brought together global CDISC leadership, regulatory experts, and life sciences professionals to discuss the latest trends and innovations in data standardization. Our team had the opportunity to engage with industry peers and contribute to...
PointCross Sponsors PHUSE SDE Hyderabad 2025
Date: Saturday, 21 June 2025Location: Hyderabad, India PointCross Life Sciences was proud to sponsor the PHUSE Single Day Event (SDE) in Hyderabad. The event brought together data science and regulatory professionals from across the life sciences industry, offering a platform to exchange ideas and drive innovation in clinical and non-clinical analytics. Featured Presentation Libin Varghese, Principal Solutions...
PointCross at PHUSE APAC SDE 2025
PointCross Life Sciences participated in PHUSE APAC SDE 2025, hosted by Hexaware Technologies, where industry experts convened to discuss Emerging Therapeutic Technologies, Precision Medicine, and Biomarker Data. Dr. Sapna Chandran (PointCross Life Sciences) and Mohit Sehgal, Ph.D. (Hexaware Technologies) contributed valuable insights on the role of automation, AI/ML, and regulatory-compliant data management in clinical...
PHUSE US Connect 2025
Date: March 16-19, 2025Location: Orlando, Florida PointCross Life Sciences participated in PHUSE US Connect 2025 in Orlando, where Harinarayan Gopichandran presented his paper, “SD03: Turbocharge Your Trials: Transform CRF Creation and the CDISC Standardization Process with Smart Metadata Repositories and AI/ML Innovations.” Key highlights included demonstrating how our MDR:• Enhances data standardization for SDTM and ADaM...
Bay Area Biotech-Pharma Statistics Workshop (BBSW)
We’re excited to announce that PointCross is sponsoring the Bay Area Biostatistics & Bioinformatics Symposium (BBSW) 2024. Date: October 24-25, 2024Location: Crowne Plaza Hotel in Foster City, CA This year’s symposium brings together brilliant minds to explore the future of biostatistics and bioinformatics, with keynote speakers: Dr. Gregory Alexander from the FDA Dr. Robert Tibshirani from Stanford University Learn...
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,...
EDC Raw Data to SDTM Curation, Mapping and Automation with the Xbiom Tool
At PHUSE US Connect 2023, PointCross Life Sciences presented a new way to automate the mapping of raw clinical EDC and non-EDC (biomarker) data to SDTM mapping through a Universal Data Model (UDM). Reducing the time to SDTM from weeks to days with built-in traceability, we discussed how SDTM programming and mapping for statistical analysis...
Tri-Con of Molecular Medicine
A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021
Validation Consistency and Conformance of SEND Datasets
DH12: Validation Consistency and Conformance Checking of SEND Datasets
PhUSE EU Connect: Amsterdam
November 10 -13 | A live demo of our offerings or learning more about the release of our eDataValidator.
PhUSE Single day event
Beerse, Belgium | September 11, 2019
A Workbench for Biomarker and Translational Research
View Recording
PhUSE 2019 Computational Science Symposium
Booth #9, Silver Spring Civic Center June 9-11, 2019 | Silver Spring, MD
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 ...
Bio-IT World Conference an Expo – 2019
Booth #638 | April 15-18, 2019 | Boston, MA
Workshop: A Workbench for Biomarker and Translational Research
April 17, 2019 | 8:00 am – 9:30am ET | Boston, MA 02210
Phuse SDE
April 4, 2019 | Foster City, California
PhUSE Connect EU – The Clinical Data Science Conference
November 4 – 8, 2018 | KAP Europa | Frankfurt, Germany
The Molecular Medicine Tri Con Conference 2018
Feb 11 – 16, 2018 | San Francisco, CA | Booth # 732
PhuSE Single Day Event Foster City
Feb 22, 2018 | Foster City Community Center | Wind Room
PhUSE CSS Computational Science Symposium
March 4 – 6, 2018 | Silver Spring, MD
Nonclinical Conferences
SOT 64th Annual Meeting
Date: March 16-20, 2025 Location: Orlando, Florida The SOT 64th Annual Meeting and ToxExpo, held from March 16-20, 2025, at the Orange County Convention Center, Orlando, FL, successfully brought together leading experts in toxicology. The event featured scientific sessions, poster presentations, and networking opportunities, along with the three-day ToxExpo showcasing the latest advancements in the field. Thank...
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...
Conference: PhUSE SDE – Canton, MI
Value of Rapid Integration of Patient Immunoassays and eCRFs in Trials | Tuesday 29 September 2020
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.
Taking full advantage of the SEND data potential
Jointly published by Roche and PointCross Lifesciences
Visualization of “Real Time” Data from Ongoing Non-Clinical Studies in Support of Study Monitoring and informed Decision Making
PointCross will be holding a joint presentation with Roche | 9th–13th November
Face-to-Face CDISC SEND at FDA
April 1 - 5, 2019
PhUSE CSS Computational Science Symposium
March 4 – 6, 2018 | Silver Spring, MD
Clinical News
Hexaware Launches Clinical Data Automation as a Solution (CDaaS) in Partnership with PointCross Life Sciences
Iselin, NJ –– Hexaware Technologies, a global provider of IT services and solutions serving X of top 20 leading pharmaceutical sponsor companies, and PointCross Life Sciences, today announced a partnership to introduce Clinical Data Automation as a Solution (CDaaS) powered by PointCross’ Xbiom™ platform. This solution is designed to enhance the clinical data lifecycle,...
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 & 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 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...