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...
Xbiom Accelerating Innovation in BioPharma
Whitepaper
Unified Machine Readable Target Data Models from Smart Transformation of Disparate Biopharma Source Data
Whitepaper - June 20, 2019
Xbiom: Translational & Biomarker Research Workbench
2 Page Brochure
Smart Transformation 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
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...
Drug Safety Information Management
Specify, Validate, Package and Review SEND data for FDA Submissions...
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...
FDA’s Binding Guidance on Electronic Study Data Submissions
On December 18th 2014, the FDA issued binding guidance regarding electronic submissions of nonclinical study data. This means that beginning in 2017, any organization making IND, NDA or BLA submissions...
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
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 Transformation – 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
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 Transformation – 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
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
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
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
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 (Â 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 (Â FDA Announcement;Â 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 (Â 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 (Â 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 Announces DSIMS™: Drug Safety Information Management Suite
FOSTER CITY, CA, March 12, 2012 PRNewswire The FDA has announced its intention to require Pharma companies to include nonclinical study data in standardized electronic formats as part of regulatory IND, NDA and BLA submissions. This directive is intended to help FDA reviewers better predict safety impacts of drugs in humans, and to improve regulatory...
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...